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Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.
Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
Crisaborole
Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.
When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
Tacrolimus
The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.
“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
Ruxolitinib
For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).
The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.
Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
Dupilumab
Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.
At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.
These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”
Ixekizumab
Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.
The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.
For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.
In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.
Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM