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Secukinumab brings high PASI 75 results in 6- to 17-year-olds with psoriasis
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).
He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.
The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.
Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.
Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.
“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.
“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.
Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”
Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.
MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Enzymatic injections show durable improvement in buttock cellulite
follow-up in an ongoing, 5-year, phase 3b, open-label extension study, Michael H. Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
However, outcomes in that study, as well as in the earlier pivotal trials, were assessed via physician and patient subjective assessments of aesthetic appearance. In a separate presentation at the conference, Michael S. Kaminer, MD, presented a different study evaluating the objective quantifiable effects of CCH on buttock cellulite dimple volume using three-dimensional imaging. The results, indicating that smaller cellulite dimples responded better than larger dimples, he noted, were unexpected.
Discussant Zoe D. Draelos, MD, who practices in High Point, N.C., and is a consulting professor of dermatology at Duke University, Durham, N.C., put the two studies in perspective, explaining that there are multiple challenges associated with the use of CCH to treat buttock cellulite, and dermatologists need to understand them in order to maximize the benefit.
“There’s definitely a market for this therapy,” she observed, noting the plethora of over-the-counter products and devices sold for removal of cellulite. “I think if you manage patient expectations, this will be a very, very successful procedure.”
In 2020, the Food and Drug Administration approved subcutaneous injections of CCH (marketed under the brand name QWO) for treatment of cellulite in women’s buttocks on the basis of the randomized RELEASE-1 and -2 trials. But while this is a new indication for CCH, it is not a new drug. The medication has been approved for years for treatment of fibrotic band contracture disorders, namely Dupuytren’s contracture and Peyronie’s disease. The mechanism of action for treatment of cellulite involves a process dubbed enzymatic subcision, in which CCH breaks down mature collagen and stimulates new collagen formation and fat redistribution in an effort to achieve smoother skin contour.
“This adds a whole new wrinkle to injectables available in dermatology. We have fillers, we have toxins, and now we have enzymatic subcision,” Dr. Draelos commented.
Durability of effects
Dr. Gold, founder of the Gold Skin Care Center and at the Tennessee Clinical Research Center, Nashville, reported on 483 women with moderate to severe buttock cellulitis who completed the 71-day, randomized, double-blind, phase 3 RELEASE-1 or RELEASE-2 studies and then enrolled in the open-label extension study. At the end of the randomized trial, 61.7% of women experienced at least a 1-level improvement on the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), compared with 36.7% of placebo controls. The key finding in the interim analysis of the extension study: After the first 6 months, during which no one received any additional therapy, 52.7% of the CCH group still had at least a 1-level improvement in PR-PCSS, compared with the randomized trial baseline, as did 32.6% of controls.
Similarly, 63% of CCH-treated patients showed at least a 1-level improvement in the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) from baseline to the end of the randomized trial, and 52.7% met that standard after 6 months off treatment in the open-label extension. In contrast, the control group had response rates of 36.7% and 32.6%. There were no long-term safety concerns, according to Dr. Gold.
Measuring cellulite dimple volume shrinkage
Dr. Kaminer and coinvestigators measured the change in cellulite dimple volume from baseline to 30 days after the final injection of 33 buttock dimples in 27 women in order to get a quantifiable sense of the effectiveness of the CCH injection. To their surprise, smaller-volume dimples up to 118 mm3 showed a mean 43% reduction in volume, a significantly better result than the 15.8% reduction seen in dimples greater than 118 mm3.
“That’s almost counterintuitive, right? You’d think that larger dimples would have a bigger improvement, but it turns out that the smaller dimples do better,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also, cellulite dimples in women age 40 and under responded significantly better than those in older women, added Dr. Kaminer, a dermatologist in private practice in Chestnut Hill, Mass., who is also on the faculty at Yale University, New Haven, Conn., and Brown University, Providence, R.I.
Challenges in using CCH therapy
Dr. Draelos, who is familiar with CCH, having worked on some earlier studies of the product, commented that “this is really the first medical treatment for cellulite that’s been proven to work.”
That being said, there are challenges with this therapy. While roughly 53% of women rated themselves as having at least a 1-level improvement after 6 months of follow-up, so did 33% of placebo-treated controls, for a placebo-subtracted 20% response.
“Is a 1-grade improvement going to be enough for women to engage in this procedure? You do need to remember that it takes multiple injections: most need at least three injections to see durable impact. And there’s discomfort during the procedure and afterwards during the healing process because the mechanism of action is enzymatic. You’re breaking down fibrous bands, and that’s a proinflammatory process. Many women who undergo this procedure may have discomfort and bruising, and they should be warned that this is not a procedure to do before taking a cruise or wearing a bikini. Also, it’s important to note that many women will have discomfort in the area where they sit, so if they have a job where they need to be sitting for long periods of time they need to plan their activities around this particular procedure,” the dermatologist said.
Another consideration: “The area they actually studied – the buttocks – is an area where I’m not sure a lot of women would expose their skin in public. I think thigh dimpling is more bothersome because it shows in shorts and other types of clothing. We need to figure out if the injections work on the posterior thighs, the most common place most postpubertal women get cellulite,” Dr. Draelos noted.
She wasn’t surprised that smaller cellulite dimples did better. Larger dimples presumably have a broader fibrous attachment and tighter fibrous band. She found the less robust outcomes in women over age 40 similarly unsurprising, since cellulitis seems to worsen with age. Cellulitis can’t really be called a disease, anyway, since it occurs in about 90% of postpubertal women.
One last tip about managing patient expectations: “Let a woman know that it’ll be better, but it won’t be gone,” she said.
Dr. Gold and Dr. Kaminer reported serving as paid investigators for and consultants to Endo Pharmaceuticals, the study sponsor and manufacturer of CCH, as well as for several other pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
follow-up in an ongoing, 5-year, phase 3b, open-label extension study, Michael H. Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
However, outcomes in that study, as well as in the earlier pivotal trials, were assessed via physician and patient subjective assessments of aesthetic appearance. In a separate presentation at the conference, Michael S. Kaminer, MD, presented a different study evaluating the objective quantifiable effects of CCH on buttock cellulite dimple volume using three-dimensional imaging. The results, indicating that smaller cellulite dimples responded better than larger dimples, he noted, were unexpected.
Discussant Zoe D. Draelos, MD, who practices in High Point, N.C., and is a consulting professor of dermatology at Duke University, Durham, N.C., put the two studies in perspective, explaining that there are multiple challenges associated with the use of CCH to treat buttock cellulite, and dermatologists need to understand them in order to maximize the benefit.
“There’s definitely a market for this therapy,” she observed, noting the plethora of over-the-counter products and devices sold for removal of cellulite. “I think if you manage patient expectations, this will be a very, very successful procedure.”
In 2020, the Food and Drug Administration approved subcutaneous injections of CCH (marketed under the brand name QWO) for treatment of cellulite in women’s buttocks on the basis of the randomized RELEASE-1 and -2 trials. But while this is a new indication for CCH, it is not a new drug. The medication has been approved for years for treatment of fibrotic band contracture disorders, namely Dupuytren’s contracture and Peyronie’s disease. The mechanism of action for treatment of cellulite involves a process dubbed enzymatic subcision, in which CCH breaks down mature collagen and stimulates new collagen formation and fat redistribution in an effort to achieve smoother skin contour.
“This adds a whole new wrinkle to injectables available in dermatology. We have fillers, we have toxins, and now we have enzymatic subcision,” Dr. Draelos commented.
Durability of effects
Dr. Gold, founder of the Gold Skin Care Center and at the Tennessee Clinical Research Center, Nashville, reported on 483 women with moderate to severe buttock cellulitis who completed the 71-day, randomized, double-blind, phase 3 RELEASE-1 or RELEASE-2 studies and then enrolled in the open-label extension study. At the end of the randomized trial, 61.7% of women experienced at least a 1-level improvement on the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), compared with 36.7% of placebo controls. The key finding in the interim analysis of the extension study: After the first 6 months, during which no one received any additional therapy, 52.7% of the CCH group still had at least a 1-level improvement in PR-PCSS, compared with the randomized trial baseline, as did 32.6% of controls.
Similarly, 63% of CCH-treated patients showed at least a 1-level improvement in the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) from baseline to the end of the randomized trial, and 52.7% met that standard after 6 months off treatment in the open-label extension. In contrast, the control group had response rates of 36.7% and 32.6%. There were no long-term safety concerns, according to Dr. Gold.
Measuring cellulite dimple volume shrinkage
Dr. Kaminer and coinvestigators measured the change in cellulite dimple volume from baseline to 30 days after the final injection of 33 buttock dimples in 27 women in order to get a quantifiable sense of the effectiveness of the CCH injection. To their surprise, smaller-volume dimples up to 118 mm3 showed a mean 43% reduction in volume, a significantly better result than the 15.8% reduction seen in dimples greater than 118 mm3.
“That’s almost counterintuitive, right? You’d think that larger dimples would have a bigger improvement, but it turns out that the smaller dimples do better,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also, cellulite dimples in women age 40 and under responded significantly better than those in older women, added Dr. Kaminer, a dermatologist in private practice in Chestnut Hill, Mass., who is also on the faculty at Yale University, New Haven, Conn., and Brown University, Providence, R.I.
Challenges in using CCH therapy
Dr. Draelos, who is familiar with CCH, having worked on some earlier studies of the product, commented that “this is really the first medical treatment for cellulite that’s been proven to work.”
That being said, there are challenges with this therapy. While roughly 53% of women rated themselves as having at least a 1-level improvement after 6 months of follow-up, so did 33% of placebo-treated controls, for a placebo-subtracted 20% response.
“Is a 1-grade improvement going to be enough for women to engage in this procedure? You do need to remember that it takes multiple injections: most need at least three injections to see durable impact. And there’s discomfort during the procedure and afterwards during the healing process because the mechanism of action is enzymatic. You’re breaking down fibrous bands, and that’s a proinflammatory process. Many women who undergo this procedure may have discomfort and bruising, and they should be warned that this is not a procedure to do before taking a cruise or wearing a bikini. Also, it’s important to note that many women will have discomfort in the area where they sit, so if they have a job where they need to be sitting for long periods of time they need to plan their activities around this particular procedure,” the dermatologist said.
Another consideration: “The area they actually studied – the buttocks – is an area where I’m not sure a lot of women would expose their skin in public. I think thigh dimpling is more bothersome because it shows in shorts and other types of clothing. We need to figure out if the injections work on the posterior thighs, the most common place most postpubertal women get cellulite,” Dr. Draelos noted.
She wasn’t surprised that smaller cellulite dimples did better. Larger dimples presumably have a broader fibrous attachment and tighter fibrous band. She found the less robust outcomes in women over age 40 similarly unsurprising, since cellulitis seems to worsen with age. Cellulitis can’t really be called a disease, anyway, since it occurs in about 90% of postpubertal women.
One last tip about managing patient expectations: “Let a woman know that it’ll be better, but it won’t be gone,” she said.
Dr. Gold and Dr. Kaminer reported serving as paid investigators for and consultants to Endo Pharmaceuticals, the study sponsor and manufacturer of CCH, as well as for several other pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
follow-up in an ongoing, 5-year, phase 3b, open-label extension study, Michael H. Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
However, outcomes in that study, as well as in the earlier pivotal trials, were assessed via physician and patient subjective assessments of aesthetic appearance. In a separate presentation at the conference, Michael S. Kaminer, MD, presented a different study evaluating the objective quantifiable effects of CCH on buttock cellulite dimple volume using three-dimensional imaging. The results, indicating that smaller cellulite dimples responded better than larger dimples, he noted, were unexpected.
Discussant Zoe D. Draelos, MD, who practices in High Point, N.C., and is a consulting professor of dermatology at Duke University, Durham, N.C., put the two studies in perspective, explaining that there are multiple challenges associated with the use of CCH to treat buttock cellulite, and dermatologists need to understand them in order to maximize the benefit.
“There’s definitely a market for this therapy,” she observed, noting the plethora of over-the-counter products and devices sold for removal of cellulite. “I think if you manage patient expectations, this will be a very, very successful procedure.”
In 2020, the Food and Drug Administration approved subcutaneous injections of CCH (marketed under the brand name QWO) for treatment of cellulite in women’s buttocks on the basis of the randomized RELEASE-1 and -2 trials. But while this is a new indication for CCH, it is not a new drug. The medication has been approved for years for treatment of fibrotic band contracture disorders, namely Dupuytren’s contracture and Peyronie’s disease. The mechanism of action for treatment of cellulite involves a process dubbed enzymatic subcision, in which CCH breaks down mature collagen and stimulates new collagen formation and fat redistribution in an effort to achieve smoother skin contour.
“This adds a whole new wrinkle to injectables available in dermatology. We have fillers, we have toxins, and now we have enzymatic subcision,” Dr. Draelos commented.
Durability of effects
Dr. Gold, founder of the Gold Skin Care Center and at the Tennessee Clinical Research Center, Nashville, reported on 483 women with moderate to severe buttock cellulitis who completed the 71-day, randomized, double-blind, phase 3 RELEASE-1 or RELEASE-2 studies and then enrolled in the open-label extension study. At the end of the randomized trial, 61.7% of women experienced at least a 1-level improvement on the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), compared with 36.7% of placebo controls. The key finding in the interim analysis of the extension study: After the first 6 months, during which no one received any additional therapy, 52.7% of the CCH group still had at least a 1-level improvement in PR-PCSS, compared with the randomized trial baseline, as did 32.6% of controls.
Similarly, 63% of CCH-treated patients showed at least a 1-level improvement in the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) from baseline to the end of the randomized trial, and 52.7% met that standard after 6 months off treatment in the open-label extension. In contrast, the control group had response rates of 36.7% and 32.6%. There were no long-term safety concerns, according to Dr. Gold.
Measuring cellulite dimple volume shrinkage
Dr. Kaminer and coinvestigators measured the change in cellulite dimple volume from baseline to 30 days after the final injection of 33 buttock dimples in 27 women in order to get a quantifiable sense of the effectiveness of the CCH injection. To their surprise, smaller-volume dimples up to 118 mm3 showed a mean 43% reduction in volume, a significantly better result than the 15.8% reduction seen in dimples greater than 118 mm3.
“That’s almost counterintuitive, right? You’d think that larger dimples would have a bigger improvement, but it turns out that the smaller dimples do better,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also, cellulite dimples in women age 40 and under responded significantly better than those in older women, added Dr. Kaminer, a dermatologist in private practice in Chestnut Hill, Mass., who is also on the faculty at Yale University, New Haven, Conn., and Brown University, Providence, R.I.
Challenges in using CCH therapy
Dr. Draelos, who is familiar with CCH, having worked on some earlier studies of the product, commented that “this is really the first medical treatment for cellulite that’s been proven to work.”
That being said, there are challenges with this therapy. While roughly 53% of women rated themselves as having at least a 1-level improvement after 6 months of follow-up, so did 33% of placebo-treated controls, for a placebo-subtracted 20% response.
“Is a 1-grade improvement going to be enough for women to engage in this procedure? You do need to remember that it takes multiple injections: most need at least three injections to see durable impact. And there’s discomfort during the procedure and afterwards during the healing process because the mechanism of action is enzymatic. You’re breaking down fibrous bands, and that’s a proinflammatory process. Many women who undergo this procedure may have discomfort and bruising, and they should be warned that this is not a procedure to do before taking a cruise or wearing a bikini. Also, it’s important to note that many women will have discomfort in the area where they sit, so if they have a job where they need to be sitting for long periods of time they need to plan their activities around this particular procedure,” the dermatologist said.
Another consideration: “The area they actually studied – the buttocks – is an area where I’m not sure a lot of women would expose their skin in public. I think thigh dimpling is more bothersome because it shows in shorts and other types of clothing. We need to figure out if the injections work on the posterior thighs, the most common place most postpubertal women get cellulite,” Dr. Draelos noted.
She wasn’t surprised that smaller cellulite dimples did better. Larger dimples presumably have a broader fibrous attachment and tighter fibrous band. She found the less robust outcomes in women over age 40 similarly unsurprising, since cellulitis seems to worsen with age. Cellulitis can’t really be called a disease, anyway, since it occurs in about 90% of postpubertal women.
One last tip about managing patient expectations: “Let a woman know that it’ll be better, but it won’t be gone,” she said.
Dr. Gold and Dr. Kaminer reported serving as paid investigators for and consultants to Endo Pharmaceuticals, the study sponsor and manufacturer of CCH, as well as for several other pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Bimekizumab superior to adalimumab in head-to-head psoriasis study
for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.
The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.
BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.
The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.
The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.
“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”
“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”
“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”
It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.
The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.
BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.
The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.
The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.
“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”
“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”
“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”
It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
for treatment of moderate to severe plaque psoriasis in the head-to-head, phase 3 BE SURE trial, Jerry Bagel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of treatment in terms of the speed, depth, and durability of skin clearance,” reported Dr. Bagel, a dermatologist at the Psoriasis Center of Central New Jersey, East Windsor.
The Food and Drug Administration is now reviewing UCB’s application for marketing approval of bimekizumab for treatment of moderate to severe psoriasis in adults.
BE SURE was a 478-patient, double-blind, phase 3 trial in which patients were randomized to one of three regimens: 320 mg of bimekizumab every 4 weeks; the tumor necrosis factor blocker adalimumab (Humira) at 40 mg every 2 weeks for 24 weeks, followed by a switch to bimekizumab at 320 mg every 4 weeks; or 320 mg of bimekizumab every 4 weeks for 16 weeks, then ratcheting back to dosing every 8 weeks. The trial concluded at week 56, Dr. Bagel explained at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The two coprimary endpoints were the 16-week rates of a 90% improvement from baseline in Psoriasis Area and Severity Index score, or PASI 90 response, and an Investigator’s Global Assessment (IGA) score of 0 or 1, meaning clear or almost clear. Bimekizumab every 4 weeks bested adalimumab on both endpoints, with a PASI 90 rate of 86.2%, compared with 47.2%, and a IGA 0/1 rate of 85.3% versus 57.2%. The 16-week PASI 100 response rate was 60.8% with bimekizumab and 23.9% with adalimumab.
The response to bimekizumab was notably fast: already by week 4, the PASI 75 rate was 76.4%, compared with 31.4% with adalimumab. And once patients switched from adalimumab to bimekizumab at week 24, their response rates shot up rapidly. Bimekizumab was equally effective whether dosed at 320 mg every 4 weeks or at maintenance dosing every 8 weeks, such that at week 56 patients in all three study arms had PASI 90 rates of 82%-84%.
The most frequent treatment-emergent adverse events associated with bimekizumab were oral candidiasis, nasopharyngitis, and upper respiratory tract infection. The oral candidiasis, which occurred in 13.2% of patients on bimekizumab every 4 weeks, was mainly mild to moderate, localized, and in no instance led to discontinuation of therapy, according to Dr. Bagel.
“Very impressive data,” commented session comoderator Linda Stein Gold, MD. “This study shows some data that’s potentially unprecedented. Bimekizumab was superior to one of the drugs that we know, we’ve used, and know is very, very effective.”
“Note the speed of this drug,” added comoderator Bruce E. Strober, MD, PhD, of Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn. “It achieved at week 4 the efficacy that it took adalimumab until week 16 to reach. So it is a very fast drug. Bimekizumab will be the fastest drug you’ve ever, ever worked with.”
“You’ll see in the bimekizumab studies about a fivefold increased frequency of oral candidiasis relative to our more legacy IL-17 inhibitors, such as ixekizumab, secukinumab, and brodalumab. I think that means approximately one in five or one in six patients will have some form of candidiasis when you treat them with bimekizumab,” he said. Therefore, he added, “in some patients you’ll have to manage oral candidiasis. Most affected patients don’t leave the studies, so it’s manageable, but you’ll have to become something of an authority on how to treat with, for example, oral antifungal swish-and-swallow, swish-and-spit, or oral fluconazole. And some of these patients will have recurrent infections.”
It’s a prospect that doesn’t concern Dr. Stein Gold. “This is a side effect that we can treat. We can see it, we’re comfortable with it, and it’s certainly something we can get a handle on,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
BE SURE was funded by UCB. Dr. Bagel reported serving as a speaker for, consultant to, and paid investigator for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis, and Ortho Pharmaceuticals. Dr. Stein Gold and Dr. Strober reported having financial relationships with numerous pharmaceutical companies.
MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Hedgehog inhibitor alternative dosing advantageous for BCC
in a successful effort to maintain efficacy while reducing treatment discontinuation caused by unacceptable side effects, Vishal Patel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“It’s the tolerability issues that make these drugs very difficult to prescribe and use regularly. What we’ve seen in the last few years is that a lot of alternative dosing regimens have been published that have been both effective at treating the tumor and keeping the tumor clear and at bay while lowering the side-effect profile,” explained Dr. Patel, a Mohs surgeon and director of the cutaneous oncology program at the George Washington University Cancer Center in Washington, D.C.
Product labeling for the two available hedgehog pathway inhibitors, vismodegib (Erivedge) and sonidegib (Odomzo), calls for once-daily therapy until disease progression or unacceptable toxicity. Studies show that, when used in this way, these agents achieve objective response rates in the 40% range for patients with locally advanced BCC and 15%-33% for those with metastatic BCC.
“The critical thing in these patients is not that the drugs work – although they can work in quite remarkable ways – but rather it’s that nearly all patients experience at least one side effect. And grade 3 or 4 adverse effects that can lead to cessation of drug occur in about 25% of patients,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The classic side effects of the hedgehog pathway inhibitors are muscle spasms, hair loss, fatigue, loss of taste, diarrhea, and weight loss.
Among the alternative dosing regimens that have been published with good results, mostly in single-center retrospective case series, are a weekdays-on/weekends-off strategy at the Cleveland Clinic and an Italian approach entailing an initial 3-4 months of daily therapy followed by a switch to alternate-day therapy.
But Dr. Patel favors a different off-label regimen in lieu of Food and Drug Administration–recommended daily dosing indefinitely. It takes advantage of the fact that most patients don’t begin to get the classic side effects until about the 3-month mark.
“What we’ve begun to recommend as a much better option for patients who need to be on the drug potentially forever is that the drug is dosed daily for 3 months to shrink the tumor and get the optimal effect, and then at that point we taper the dose down to every other day, then every third day, or even up to a week as long as the tumor continues to stay at bay. If there’s any sign of recurrence or a scouting biopsy shows tumor, we reinstitute the daily medicine,” the dermatologist said.
This strategy requires careful monitoring for emergence of the typical side effects. Also, an important caveat regarding sonidegib is that it shouldn’t be given concomitantly with medications that are moderate or strong inhibitors of CYP3A, so it’s essential to get a complete medical history when giving this drug, Dr. Patel noted.
He reported having no financial conflicts regarding his presentation.
MedscapeLIVE! and this news organization are owned by the same parent company.
in a successful effort to maintain efficacy while reducing treatment discontinuation caused by unacceptable side effects, Vishal Patel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“It’s the tolerability issues that make these drugs very difficult to prescribe and use regularly. What we’ve seen in the last few years is that a lot of alternative dosing regimens have been published that have been both effective at treating the tumor and keeping the tumor clear and at bay while lowering the side-effect profile,” explained Dr. Patel, a Mohs surgeon and director of the cutaneous oncology program at the George Washington University Cancer Center in Washington, D.C.
Product labeling for the two available hedgehog pathway inhibitors, vismodegib (Erivedge) and sonidegib (Odomzo), calls for once-daily therapy until disease progression or unacceptable toxicity. Studies show that, when used in this way, these agents achieve objective response rates in the 40% range for patients with locally advanced BCC and 15%-33% for those with metastatic BCC.
“The critical thing in these patients is not that the drugs work – although they can work in quite remarkable ways – but rather it’s that nearly all patients experience at least one side effect. And grade 3 or 4 adverse effects that can lead to cessation of drug occur in about 25% of patients,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The classic side effects of the hedgehog pathway inhibitors are muscle spasms, hair loss, fatigue, loss of taste, diarrhea, and weight loss.
Among the alternative dosing regimens that have been published with good results, mostly in single-center retrospective case series, are a weekdays-on/weekends-off strategy at the Cleveland Clinic and an Italian approach entailing an initial 3-4 months of daily therapy followed by a switch to alternate-day therapy.
But Dr. Patel favors a different off-label regimen in lieu of Food and Drug Administration–recommended daily dosing indefinitely. It takes advantage of the fact that most patients don’t begin to get the classic side effects until about the 3-month mark.
“What we’ve begun to recommend as a much better option for patients who need to be on the drug potentially forever is that the drug is dosed daily for 3 months to shrink the tumor and get the optimal effect, and then at that point we taper the dose down to every other day, then every third day, or even up to a week as long as the tumor continues to stay at bay. If there’s any sign of recurrence or a scouting biopsy shows tumor, we reinstitute the daily medicine,” the dermatologist said.
This strategy requires careful monitoring for emergence of the typical side effects. Also, an important caveat regarding sonidegib is that it shouldn’t be given concomitantly with medications that are moderate or strong inhibitors of CYP3A, so it’s essential to get a complete medical history when giving this drug, Dr. Patel noted.
He reported having no financial conflicts regarding his presentation.
MedscapeLIVE! and this news organization are owned by the same parent company.
in a successful effort to maintain efficacy while reducing treatment discontinuation caused by unacceptable side effects, Vishal Patel, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
“It’s the tolerability issues that make these drugs very difficult to prescribe and use regularly. What we’ve seen in the last few years is that a lot of alternative dosing regimens have been published that have been both effective at treating the tumor and keeping the tumor clear and at bay while lowering the side-effect profile,” explained Dr. Patel, a Mohs surgeon and director of the cutaneous oncology program at the George Washington University Cancer Center in Washington, D.C.
Product labeling for the two available hedgehog pathway inhibitors, vismodegib (Erivedge) and sonidegib (Odomzo), calls for once-daily therapy until disease progression or unacceptable toxicity. Studies show that, when used in this way, these agents achieve objective response rates in the 40% range for patients with locally advanced BCC and 15%-33% for those with metastatic BCC.
“The critical thing in these patients is not that the drugs work – although they can work in quite remarkable ways – but rather it’s that nearly all patients experience at least one side effect. And grade 3 or 4 adverse effects that can lead to cessation of drug occur in about 25% of patients,” he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The classic side effects of the hedgehog pathway inhibitors are muscle spasms, hair loss, fatigue, loss of taste, diarrhea, and weight loss.
Among the alternative dosing regimens that have been published with good results, mostly in single-center retrospective case series, are a weekdays-on/weekends-off strategy at the Cleveland Clinic and an Italian approach entailing an initial 3-4 months of daily therapy followed by a switch to alternate-day therapy.
But Dr. Patel favors a different off-label regimen in lieu of Food and Drug Administration–recommended daily dosing indefinitely. It takes advantage of the fact that most patients don’t begin to get the classic side effects until about the 3-month mark.
“What we’ve begun to recommend as a much better option for patients who need to be on the drug potentially forever is that the drug is dosed daily for 3 months to shrink the tumor and get the optimal effect, and then at that point we taper the dose down to every other day, then every third day, or even up to a week as long as the tumor continues to stay at bay. If there’s any sign of recurrence or a scouting biopsy shows tumor, we reinstitute the daily medicine,” the dermatologist said.
This strategy requires careful monitoring for emergence of the typical side effects. Also, an important caveat regarding sonidegib is that it shouldn’t be given concomitantly with medications that are moderate or strong inhibitors of CYP3A, so it’s essential to get a complete medical history when giving this drug, Dr. Patel noted.
He reported having no financial conflicts regarding his presentation.
MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Oral sarecycline promising for papulopustular rosacea
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
National Psoriasis Foundation recommends some stop methotrexate for 2 weeks after J&J vaccine
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Will psoriasis patients embrace proactive topical therapy?
Long-term proactive topical management of plaque psoriasis with twice-weekly calcipotriene/betamethasone dipropionate foam has been shown in a high-quality randomized trial to be more effective than conventional reactive management – but will patients go for it?
Bruce E. Strober, MD, PhD, has his doubts, and he shared them with Linda Stein Gold, MD, after she presented updated results from the 52-week PSO-LONG trial at Innovations in Dermatology: Virtual Spring Conference 2021.
. And while they did so in this study with an assist in the form of monthly office visits and nudging from investigators, in real-world clinical practice that’s unlikely to happen, according to Dr. Strober, of Yale University, New Haven, Conn.
“It makes sense to do what’s being done in this study, there’s no doubt, but I’m concerned about adherence and whether patients are really going to do it,” he said.
“Adherence is going to be everything here, and you know patients don’t like to apply topicals to their body. Once they’re clear they’re just going to walk away from the topical,” Dr. Strober predicted.
Dr. Stein Gold countered: “When a study goes on for a full year, it starts to reflect real life.”
Moreover, the PSO-LONG trial provides the first high-quality evidence physicians can share with patients demonstrating that proactive management pays off in terms of fewer relapses and more time in remission over the long haul, added Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
PSO-LONG was a double-blind, international, phase 3 study including 545 adults with plaque psoriasis who had clear or almost-clear skin after 4 weeks of once-daily calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam (Enstilar), and were then randomized to twice-weekly proactive management or to a reactive approach involving application of vehicle on the same twice-weekly schedule. Relapses resulted in rescue therapy with 4 weeks of once-daily Cal/BD foam.
The primary endpoint was the median time to first relapse: 56 days with the proactive approach, a significant improvement over the 30 days with the reactive approach. Over the course of 52 weeks, the proactive group spent an additional 41 days in remission, compared with the reactive group. Patients randomized to twice-weekly Cal/BD foam averaged 3.1 relapses per year, compared with 4.8 with reactive management. The side-effect profiles in the two study arms were similar.
Mean Physician Global Assessment scores and Psoriasis Area and Activity Index scores for the proactive group clearly separated from the reactive group by week 4, with those differences maintained throughout the year. The area under the curve for distribution for the Physician Global Assessment score was 15% lower in the proactive group, and 20% lower for the modified PASI score.
“These results suggest that proactive management – a concept that’s been used for atopic dermatitis – could be applied to patients with psoriasis to prolong remission,” Dr. Stein Gold concluded at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Asked how confident she is that patients in the real world truly will do this, Dr. Stein Gold replied: “You know, I don’t know. We hope so. Now we can tell them we actually have some data that supports treating the cleared areas. And it’s only twice a week, separated on Mondays and Thursdays.”
“I take a much more reactive approach,” Dr. Strober said. “I advise patients to get back in there with their topical steroid as soon as they see any signs of recurrence.
He added that he’s eager to see if a proactive management approach such as the one that was successful in PSO-LONG is also beneficial using some of the promising topical agents with nonsteroidal mechanisms of action, which are advancing through the developmental pipeline.
Late in 2020, the Food and Drug Administration approved an expanded indication for Cal/BD foam, which includes the PSO-LONG data on the efficacy and safety of long-term twice-weekly therapy in adults in product labeling. The combination spray/foam was previously approved by the FDA as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid as daily therapy.
The PSO-LONG trial was funded by LEO Pharma. Dr. Stein Gold reported serving as a paid investigator and/or consultant to LEO and numerous other pharmaceutical companies. Dr. Strober, reported serving as a consultant to more than two dozen pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Long-term proactive topical management of plaque psoriasis with twice-weekly calcipotriene/betamethasone dipropionate foam has been shown in a high-quality randomized trial to be more effective than conventional reactive management – but will patients go for it?
Bruce E. Strober, MD, PhD, has his doubts, and he shared them with Linda Stein Gold, MD, after she presented updated results from the 52-week PSO-LONG trial at Innovations in Dermatology: Virtual Spring Conference 2021.
. And while they did so in this study with an assist in the form of monthly office visits and nudging from investigators, in real-world clinical practice that’s unlikely to happen, according to Dr. Strober, of Yale University, New Haven, Conn.
“It makes sense to do what’s being done in this study, there’s no doubt, but I’m concerned about adherence and whether patients are really going to do it,” he said.
“Adherence is going to be everything here, and you know patients don’t like to apply topicals to their body. Once they’re clear they’re just going to walk away from the topical,” Dr. Strober predicted.
Dr. Stein Gold countered: “When a study goes on for a full year, it starts to reflect real life.”
Moreover, the PSO-LONG trial provides the first high-quality evidence physicians can share with patients demonstrating that proactive management pays off in terms of fewer relapses and more time in remission over the long haul, added Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
PSO-LONG was a double-blind, international, phase 3 study including 545 adults with plaque psoriasis who had clear or almost-clear skin after 4 weeks of once-daily calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam (Enstilar), and were then randomized to twice-weekly proactive management or to a reactive approach involving application of vehicle on the same twice-weekly schedule. Relapses resulted in rescue therapy with 4 weeks of once-daily Cal/BD foam.
The primary endpoint was the median time to first relapse: 56 days with the proactive approach, a significant improvement over the 30 days with the reactive approach. Over the course of 52 weeks, the proactive group spent an additional 41 days in remission, compared with the reactive group. Patients randomized to twice-weekly Cal/BD foam averaged 3.1 relapses per year, compared with 4.8 with reactive management. The side-effect profiles in the two study arms were similar.
Mean Physician Global Assessment scores and Psoriasis Area and Activity Index scores for the proactive group clearly separated from the reactive group by week 4, with those differences maintained throughout the year. The area under the curve for distribution for the Physician Global Assessment score was 15% lower in the proactive group, and 20% lower for the modified PASI score.
“These results suggest that proactive management – a concept that’s been used for atopic dermatitis – could be applied to patients with psoriasis to prolong remission,” Dr. Stein Gold concluded at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Asked how confident she is that patients in the real world truly will do this, Dr. Stein Gold replied: “You know, I don’t know. We hope so. Now we can tell them we actually have some data that supports treating the cleared areas. And it’s only twice a week, separated on Mondays and Thursdays.”
“I take a much more reactive approach,” Dr. Strober said. “I advise patients to get back in there with their topical steroid as soon as they see any signs of recurrence.
He added that he’s eager to see if a proactive management approach such as the one that was successful in PSO-LONG is also beneficial using some of the promising topical agents with nonsteroidal mechanisms of action, which are advancing through the developmental pipeline.
Late in 2020, the Food and Drug Administration approved an expanded indication for Cal/BD foam, which includes the PSO-LONG data on the efficacy and safety of long-term twice-weekly therapy in adults in product labeling. The combination spray/foam was previously approved by the FDA as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid as daily therapy.
The PSO-LONG trial was funded by LEO Pharma. Dr. Stein Gold reported serving as a paid investigator and/or consultant to LEO and numerous other pharmaceutical companies. Dr. Strober, reported serving as a consultant to more than two dozen pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Long-term proactive topical management of plaque psoriasis with twice-weekly calcipotriene/betamethasone dipropionate foam has been shown in a high-quality randomized trial to be more effective than conventional reactive management – but will patients go for it?
Bruce E. Strober, MD, PhD, has his doubts, and he shared them with Linda Stein Gold, MD, after she presented updated results from the 52-week PSO-LONG trial at Innovations in Dermatology: Virtual Spring Conference 2021.
. And while they did so in this study with an assist in the form of monthly office visits and nudging from investigators, in real-world clinical practice that’s unlikely to happen, according to Dr. Strober, of Yale University, New Haven, Conn.
“It makes sense to do what’s being done in this study, there’s no doubt, but I’m concerned about adherence and whether patients are really going to do it,” he said.
“Adherence is going to be everything here, and you know patients don’t like to apply topicals to their body. Once they’re clear they’re just going to walk away from the topical,” Dr. Strober predicted.
Dr. Stein Gold countered: “When a study goes on for a full year, it starts to reflect real life.”
Moreover, the PSO-LONG trial provides the first high-quality evidence physicians can share with patients demonstrating that proactive management pays off in terms of fewer relapses and more time in remission over the long haul, added Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit.
PSO-LONG was a double-blind, international, phase 3 study including 545 adults with plaque psoriasis who had clear or almost-clear skin after 4 weeks of once-daily calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam (Enstilar), and were then randomized to twice-weekly proactive management or to a reactive approach involving application of vehicle on the same twice-weekly schedule. Relapses resulted in rescue therapy with 4 weeks of once-daily Cal/BD foam.
The primary endpoint was the median time to first relapse: 56 days with the proactive approach, a significant improvement over the 30 days with the reactive approach. Over the course of 52 weeks, the proactive group spent an additional 41 days in remission, compared with the reactive group. Patients randomized to twice-weekly Cal/BD foam averaged 3.1 relapses per year, compared with 4.8 with reactive management. The side-effect profiles in the two study arms were similar.
Mean Physician Global Assessment scores and Psoriasis Area and Activity Index scores for the proactive group clearly separated from the reactive group by week 4, with those differences maintained throughout the year. The area under the curve for distribution for the Physician Global Assessment score was 15% lower in the proactive group, and 20% lower for the modified PASI score.
“These results suggest that proactive management – a concept that’s been used for atopic dermatitis – could be applied to patients with psoriasis to prolong remission,” Dr. Stein Gold concluded at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Asked how confident she is that patients in the real world truly will do this, Dr. Stein Gold replied: “You know, I don’t know. We hope so. Now we can tell them we actually have some data that supports treating the cleared areas. And it’s only twice a week, separated on Mondays and Thursdays.”
“I take a much more reactive approach,” Dr. Strober said. “I advise patients to get back in there with their topical steroid as soon as they see any signs of recurrence.
He added that he’s eager to see if a proactive management approach such as the one that was successful in PSO-LONG is also beneficial using some of the promising topical agents with nonsteroidal mechanisms of action, which are advancing through the developmental pipeline.
Late in 2020, the Food and Drug Administration approved an expanded indication for Cal/BD foam, which includes the PSO-LONG data on the efficacy and safety of long-term twice-weekly therapy in adults in product labeling. The combination spray/foam was previously approved by the FDA as once-daily therapy in psoriasis patients aged 12 years and older, but only for up to 4 weeks because of safety concerns regarding longer use of the potent topical steroid as daily therapy.
The PSO-LONG trial was funded by LEO Pharma. Dr. Stein Gold reported serving as a paid investigator and/or consultant to LEO and numerous other pharmaceutical companies. Dr. Strober, reported serving as a consultant to more than two dozen pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
Baricitinib hits mark for severe alopecia areata
in the phase 2/3 BRAVE-AA1 randomized trial, Brett King, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
The results with the 4-mg/day dose of the Janus kinase (JAK) 1 and -2 inhibitor were even more impressive. However, this higher dose, while approved in Europe and elsewhere for the treatment of rheumatoid arthritis, was rejected by the Food and Drug Administration because of safety concerns and is not available in the United States. The 2-mg dose of baricitinib is approved for RA in the United States.
There are currently no FDA-approved treatments for alopecia areata, noted Dr. King, a dermatologist at Yale University, New Haven, Conn.
He reported on 110 adults with severe alopecia areata as defined by a baseline Severity of Alopecia Tool (SALT) score of 87, meaning they averaged 87% scalp hair loss. They averaged a 16-year history of the autoimmune disease. The duration of the current episode was at least 4 years in more than one-third of participants. Clinicians rated more than three-quarters of patients as having no eyebrow or eyelash hair, or significant gaps and uneven distribution.
The primary outcome in this interim analysis was achievement of a SALT score of 20 or less at week 36, meaning hair loss had shrunk to 20% or less of the scalp. Fifty-two percent of patients on baricitinib 4 mg achieved this outcome, as did 33% of those randomized to baricitinib 2 mg and 4% of placebo-treated controls.
In addition, 60% of patients on the higher dose of the JAK inhibitor and 40% on the lower dose rated themselves as having either full eyebrows and eyelashes on both eyes at 36 weeks, or only minimal gaps with even distribution. None of the controls reported comparable improvement, Dr. King said at the conference, which was sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
There were no serious adverse events in this relatively small study. Six cases of herpes simplex and two of herpes zoster occurred in baricitinib-treated patients; there were none in controls.
Session moderator Andrea L. Zaenglein, MD, professor of dermatology and pediatric dermatology at Penn State University, Hershey, said that she was very impressed that baricitinib could achieve substantial hair regrowth in patients with a median duration of hair loss of about 16 years.
“It’s very interesting,” agreed comoderator Ashfaq A. Marghoob, MD, director of clinical dermatology at Memorial Sloan Kettering Cancer Center in Hauppauge, N.Y. “Having this kind of hair regrowth goes against what we learned in our residency, that the longer you’ve gone with hair loss, the less likely it is to ever come back.”
Separately, Eli Lilly issued a press release announcing that both the 2- and 4-mg doses of baricitinib had met the primary endpoint in the phase 3 BRAVE-AA2 trial, showing significantly greater hair regrowth compared with placebo in the 546-patient study. However, the company provided no data, instead stating that the full results will be presented at an upcoming medical conference.
in the phase 2/3 BRAVE-AA1 randomized trial, Brett King, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
The results with the 4-mg/day dose of the Janus kinase (JAK) 1 and -2 inhibitor were even more impressive. However, this higher dose, while approved in Europe and elsewhere for the treatment of rheumatoid arthritis, was rejected by the Food and Drug Administration because of safety concerns and is not available in the United States. The 2-mg dose of baricitinib is approved for RA in the United States.
There are currently no FDA-approved treatments for alopecia areata, noted Dr. King, a dermatologist at Yale University, New Haven, Conn.
He reported on 110 adults with severe alopecia areata as defined by a baseline Severity of Alopecia Tool (SALT) score of 87, meaning they averaged 87% scalp hair loss. They averaged a 16-year history of the autoimmune disease. The duration of the current episode was at least 4 years in more than one-third of participants. Clinicians rated more than three-quarters of patients as having no eyebrow or eyelash hair, or significant gaps and uneven distribution.
The primary outcome in this interim analysis was achievement of a SALT score of 20 or less at week 36, meaning hair loss had shrunk to 20% or less of the scalp. Fifty-two percent of patients on baricitinib 4 mg achieved this outcome, as did 33% of those randomized to baricitinib 2 mg and 4% of placebo-treated controls.
In addition, 60% of patients on the higher dose of the JAK inhibitor and 40% on the lower dose rated themselves as having either full eyebrows and eyelashes on both eyes at 36 weeks, or only minimal gaps with even distribution. None of the controls reported comparable improvement, Dr. King said at the conference, which was sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
There were no serious adverse events in this relatively small study. Six cases of herpes simplex and two of herpes zoster occurred in baricitinib-treated patients; there were none in controls.
Session moderator Andrea L. Zaenglein, MD, professor of dermatology and pediatric dermatology at Penn State University, Hershey, said that she was very impressed that baricitinib could achieve substantial hair regrowth in patients with a median duration of hair loss of about 16 years.
“It’s very interesting,” agreed comoderator Ashfaq A. Marghoob, MD, director of clinical dermatology at Memorial Sloan Kettering Cancer Center in Hauppauge, N.Y. “Having this kind of hair regrowth goes against what we learned in our residency, that the longer you’ve gone with hair loss, the less likely it is to ever come back.”
Separately, Eli Lilly issued a press release announcing that both the 2- and 4-mg doses of baricitinib had met the primary endpoint in the phase 3 BRAVE-AA2 trial, showing significantly greater hair regrowth compared with placebo in the 546-patient study. However, the company provided no data, instead stating that the full results will be presented at an upcoming medical conference.
in the phase 2/3 BRAVE-AA1 randomized trial, Brett King, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.
The results with the 4-mg/day dose of the Janus kinase (JAK) 1 and -2 inhibitor were even more impressive. However, this higher dose, while approved in Europe and elsewhere for the treatment of rheumatoid arthritis, was rejected by the Food and Drug Administration because of safety concerns and is not available in the United States. The 2-mg dose of baricitinib is approved for RA in the United States.
There are currently no FDA-approved treatments for alopecia areata, noted Dr. King, a dermatologist at Yale University, New Haven, Conn.
He reported on 110 adults with severe alopecia areata as defined by a baseline Severity of Alopecia Tool (SALT) score of 87, meaning they averaged 87% scalp hair loss. They averaged a 16-year history of the autoimmune disease. The duration of the current episode was at least 4 years in more than one-third of participants. Clinicians rated more than three-quarters of patients as having no eyebrow or eyelash hair, or significant gaps and uneven distribution.
The primary outcome in this interim analysis was achievement of a SALT score of 20 or less at week 36, meaning hair loss had shrunk to 20% or less of the scalp. Fifty-two percent of patients on baricitinib 4 mg achieved this outcome, as did 33% of those randomized to baricitinib 2 mg and 4% of placebo-treated controls.
In addition, 60% of patients on the higher dose of the JAK inhibitor and 40% on the lower dose rated themselves as having either full eyebrows and eyelashes on both eyes at 36 weeks, or only minimal gaps with even distribution. None of the controls reported comparable improvement, Dr. King said at the conference, which was sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
There were no serious adverse events in this relatively small study. Six cases of herpes simplex and two of herpes zoster occurred in baricitinib-treated patients; there were none in controls.
Session moderator Andrea L. Zaenglein, MD, professor of dermatology and pediatric dermatology at Penn State University, Hershey, said that she was very impressed that baricitinib could achieve substantial hair regrowth in patients with a median duration of hair loss of about 16 years.
“It’s very interesting,” agreed comoderator Ashfaq A. Marghoob, MD, director of clinical dermatology at Memorial Sloan Kettering Cancer Center in Hauppauge, N.Y. “Having this kind of hair regrowth goes against what we learned in our residency, that the longer you’ve gone with hair loss, the less likely it is to ever come back.”
Separately, Eli Lilly issued a press release announcing that both the 2- and 4-mg doses of baricitinib had met the primary endpoint in the phase 3 BRAVE-AA2 trial, showing significantly greater hair regrowth compared with placebo in the 546-patient study. However, the company provided no data, instead stating that the full results will be presented at an upcoming medical conference.
FROM INNOVATIONS IN DERMATOLOGY
Ruxolitinib cream for atopic dermatitis is in regulatory home stretch
, demonstrated a dual mechanism of action in two pivotal phase 3 trials: antipruritic and anti-inflammatory, Kim A. Papp, MD, PhD, said at Innovations in Dermatology: Virtual Spring Conference 2021. He presented a pooled analysis of the TRuE-AD1 and TRuE-AD2 trials, in which 1,249 patients with AD affecting 3%-20% of the body surface area were randomized 2:2:1 double-blind to ruxolitinib cream 0.75%, 1.5%, or vehicle twice daily for 8 weeks.
Striking evidence of the drug’s antipruritic effect comes from the finding that patient-reported itch scores separated significantly from the vehicle controls within just 12 hours after the first application. The margin of difference grew over time such that at 4 weeks, 48.5% of patients on ruxolitinib 1.5% experienced a clinically meaningful reduction in itch – defined by at least a 4-point improvement on the itch numeric rating scale – as did 30.1% of those on ruxolitinib 0.75% and 6.1% of controls. By week 8, these figures had further improved to 51.5%, 41.5%, and 15.8%, respectively, noted Dr. Papp, a dermatologist and president of Probity Medical Research in Waterloo, Ont.
Ruxolitinib’s anti-inflammatory mechanism of action was on display in the primary study endpoint, which was the proportion of patients achieving an Investigator Global Assessment score of 0 or 1 with at least a 2-grade improvement from baseline at week 8. The rates were 52.6% with ruxolitinib 1.5% and 44.7% at the lower dose, both significantly better than the 11.5% rate with vehicle.
For the secondary endpoint of at least a 75% improvement in Eczema Area and Severity Index score at week 8, the rates were 62% with ruxolitinib 1.5% and 53.8% at the 0.75% concentration, compared with 19.7% with vehicle.
The topical JAK inhibitor also showed superior efficacy in terms of improvement on the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Score, with a clinically meaningful 6-point or greater improvement in 23.9% and 20.9% of patients in the high- and low-dose ruxolitinib groups, versus 14.2% in controls.
Plasma drug levels remained consistently low and near-flat throughout the study.
Session comoderator Lawrence F. Eichenfield, MD, was struck by what he termed the “incredibly low” rates of irritancy, burning, and stinging in the ruxolitinib-treated patients: 7 cases of application-site burning in 999 treated patients, compared with 11 cases in 250 vehicle-treated patients, and 4 cases of application-site pruritus in nearly 1,000 patients on ruxolitinib, versus 6 cases in one-fourth as many controls.
“If that’s really true in clinical practice, it would be tremendous to have a nonsteroid that doesn’t have stinging and burning and may have that efficacy,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice-chair of dermatology at the University of California, San Diego.
“I think the fast action is an exciting aspect of this,” said comoderator Jonathan I. Silverberg, MD, PhD, MBA, director of clinical research and contact dermatitis in the department of dermatology at George Washington University in Washington.
He noted that in an earlier phase 2 study, ruxolitinib cream was at least as efficacious as 0.1% triamcinolone cream, providing dermatologists with a rough yardstick as to where the topical JAK inhibitor lies on the potency spectrum for AD treatment.
The FDA is expected to issue a decision on the application for approval of ruxolitinib cream in June. Dr. Eichenfield expects the drug to easily win approval. The big unanswered question is whether the regulatory agency will require boxed safety warnings, as it does for the oral JAK inhibitors approved for various indications, even though safety issues haven’t arisen with the topical agent in the clinical trials.
Dr. Papp reported receiving research grants from and serving as a consultant to Incyte Corp., which funded the ruxolitinib studies, as well as numerous other pharmaceutical companies. MedscapeLive and this news organization are owned by the same parent company.
, demonstrated a dual mechanism of action in two pivotal phase 3 trials: antipruritic and anti-inflammatory, Kim A. Papp, MD, PhD, said at Innovations in Dermatology: Virtual Spring Conference 2021. He presented a pooled analysis of the TRuE-AD1 and TRuE-AD2 trials, in which 1,249 patients with AD affecting 3%-20% of the body surface area were randomized 2:2:1 double-blind to ruxolitinib cream 0.75%, 1.5%, or vehicle twice daily for 8 weeks.
Striking evidence of the drug’s antipruritic effect comes from the finding that patient-reported itch scores separated significantly from the vehicle controls within just 12 hours after the first application. The margin of difference grew over time such that at 4 weeks, 48.5% of patients on ruxolitinib 1.5% experienced a clinically meaningful reduction in itch – defined by at least a 4-point improvement on the itch numeric rating scale – as did 30.1% of those on ruxolitinib 0.75% and 6.1% of controls. By week 8, these figures had further improved to 51.5%, 41.5%, and 15.8%, respectively, noted Dr. Papp, a dermatologist and president of Probity Medical Research in Waterloo, Ont.
Ruxolitinib’s anti-inflammatory mechanism of action was on display in the primary study endpoint, which was the proportion of patients achieving an Investigator Global Assessment score of 0 or 1 with at least a 2-grade improvement from baseline at week 8. The rates were 52.6% with ruxolitinib 1.5% and 44.7% at the lower dose, both significantly better than the 11.5% rate with vehicle.
For the secondary endpoint of at least a 75% improvement in Eczema Area and Severity Index score at week 8, the rates were 62% with ruxolitinib 1.5% and 53.8% at the 0.75% concentration, compared with 19.7% with vehicle.
The topical JAK inhibitor also showed superior efficacy in terms of improvement on the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Score, with a clinically meaningful 6-point or greater improvement in 23.9% and 20.9% of patients in the high- and low-dose ruxolitinib groups, versus 14.2% in controls.
Plasma drug levels remained consistently low and near-flat throughout the study.
Session comoderator Lawrence F. Eichenfield, MD, was struck by what he termed the “incredibly low” rates of irritancy, burning, and stinging in the ruxolitinib-treated patients: 7 cases of application-site burning in 999 treated patients, compared with 11 cases in 250 vehicle-treated patients, and 4 cases of application-site pruritus in nearly 1,000 patients on ruxolitinib, versus 6 cases in one-fourth as many controls.
“If that’s really true in clinical practice, it would be tremendous to have a nonsteroid that doesn’t have stinging and burning and may have that efficacy,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice-chair of dermatology at the University of California, San Diego.
“I think the fast action is an exciting aspect of this,” said comoderator Jonathan I. Silverberg, MD, PhD, MBA, director of clinical research and contact dermatitis in the department of dermatology at George Washington University in Washington.
He noted that in an earlier phase 2 study, ruxolitinib cream was at least as efficacious as 0.1% triamcinolone cream, providing dermatologists with a rough yardstick as to where the topical JAK inhibitor lies on the potency spectrum for AD treatment.
The FDA is expected to issue a decision on the application for approval of ruxolitinib cream in June. Dr. Eichenfield expects the drug to easily win approval. The big unanswered question is whether the regulatory agency will require boxed safety warnings, as it does for the oral JAK inhibitors approved for various indications, even though safety issues haven’t arisen with the topical agent in the clinical trials.
Dr. Papp reported receiving research grants from and serving as a consultant to Incyte Corp., which funded the ruxolitinib studies, as well as numerous other pharmaceutical companies. MedscapeLive and this news organization are owned by the same parent company.
, demonstrated a dual mechanism of action in two pivotal phase 3 trials: antipruritic and anti-inflammatory, Kim A. Papp, MD, PhD, said at Innovations in Dermatology: Virtual Spring Conference 2021. He presented a pooled analysis of the TRuE-AD1 and TRuE-AD2 trials, in which 1,249 patients with AD affecting 3%-20% of the body surface area were randomized 2:2:1 double-blind to ruxolitinib cream 0.75%, 1.5%, or vehicle twice daily for 8 weeks.
Striking evidence of the drug’s antipruritic effect comes from the finding that patient-reported itch scores separated significantly from the vehicle controls within just 12 hours after the first application. The margin of difference grew over time such that at 4 weeks, 48.5% of patients on ruxolitinib 1.5% experienced a clinically meaningful reduction in itch – defined by at least a 4-point improvement on the itch numeric rating scale – as did 30.1% of those on ruxolitinib 0.75% and 6.1% of controls. By week 8, these figures had further improved to 51.5%, 41.5%, and 15.8%, respectively, noted Dr. Papp, a dermatologist and president of Probity Medical Research in Waterloo, Ont.
Ruxolitinib’s anti-inflammatory mechanism of action was on display in the primary study endpoint, which was the proportion of patients achieving an Investigator Global Assessment score of 0 or 1 with at least a 2-grade improvement from baseline at week 8. The rates were 52.6% with ruxolitinib 1.5% and 44.7% at the lower dose, both significantly better than the 11.5% rate with vehicle.
For the secondary endpoint of at least a 75% improvement in Eczema Area and Severity Index score at week 8, the rates were 62% with ruxolitinib 1.5% and 53.8% at the 0.75% concentration, compared with 19.7% with vehicle.
The topical JAK inhibitor also showed superior efficacy in terms of improvement on the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Score, with a clinically meaningful 6-point or greater improvement in 23.9% and 20.9% of patients in the high- and low-dose ruxolitinib groups, versus 14.2% in controls.
Plasma drug levels remained consistently low and near-flat throughout the study.
Session comoderator Lawrence F. Eichenfield, MD, was struck by what he termed the “incredibly low” rates of irritancy, burning, and stinging in the ruxolitinib-treated patients: 7 cases of application-site burning in 999 treated patients, compared with 11 cases in 250 vehicle-treated patients, and 4 cases of application-site pruritus in nearly 1,000 patients on ruxolitinib, versus 6 cases in one-fourth as many controls.
“If that’s really true in clinical practice, it would be tremendous to have a nonsteroid that doesn’t have stinging and burning and may have that efficacy,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice-chair of dermatology at the University of California, San Diego.
“I think the fast action is an exciting aspect of this,” said comoderator Jonathan I. Silverberg, MD, PhD, MBA, director of clinical research and contact dermatitis in the department of dermatology at George Washington University in Washington.
He noted that in an earlier phase 2 study, ruxolitinib cream was at least as efficacious as 0.1% triamcinolone cream, providing dermatologists with a rough yardstick as to where the topical JAK inhibitor lies on the potency spectrum for AD treatment.
The FDA is expected to issue a decision on the application for approval of ruxolitinib cream in June. Dr. Eichenfield expects the drug to easily win approval. The big unanswered question is whether the regulatory agency will require boxed safety warnings, as it does for the oral JAK inhibitors approved for various indications, even though safety issues haven’t arisen with the topical agent in the clinical trials.
Dr. Papp reported receiving research grants from and serving as a consultant to Incyte Corp., which funded the ruxolitinib studies, as well as numerous other pharmaceutical companies. MedscapeLive and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY