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The approval of dupilumab, the first targeted biologic therapy approved in the United States for treatment of atopic dermatitis, provides a welcome, long-awaited alternative to currently available therapies for moderate to severe disease, according to two of the pivotal trial investigators.
In late March, the Food and Drug Administration approved dupilumab, a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, for the treatment of moderate to severe AD in adults “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.” It is administered subcutaneously, with an initial 600-mg dose, followed by 300 mg every other week, according to the prescribing information.
Dupilumab (Dupixent) was the second novel treatment approved for AD in less than 4 months – after years of no approvals of new therapies for this indication. In December, crisaborole ointment (Eucrisa) was approved for treatment of mild to moderate AD in patients aged 2 years and older. Crisaborole is a topical phosphodiesterase-4 inhibitor.
Dupilumab’s approval was based on three phase III studies of adults with moderate to severe AD: SOLO-1 and SOLO-2, which evaluated dupilumab as monotherapy, and the CHRONOS study, which compared dupilumab with topical corticosteroids to treatment with topical corticosteroids alone.
At 16 weeks in the SOLO trials, those treated with dupilumab had improvements in signs and symptoms of AD, including pruritus, anxiety and depression, and quality of life, compared with placebo. Almost 40% of those treated with dupilumab met the primary outcome – a score of clear or almost clear on the Investigator’s Global Assessment and a reduction of 2 points or more in that score from baseline – compared with 8%-10% of those on placebo (P less than .001). Injection-site reactions and conjunctivitis were more common among those treated with dupilumab (N Engl J Med. 2016;375:2335-48).
Emma Guttman-Yassky, MD, PhD, also an investigator in the SOLO 1 and SOLO 2 trials, said that prior to the approval, “we had nothing to treat our patients safely long term.”
“With dupilumab, because it’s specific, it provides the safety that we need,” while providing efficacy that is similar to or better than that of cyclosporine, with the caveat that dupilumab and cyclosporine have not been evaluated in a head-to-head study, Dr. Guttman-Yassky, professor and vice-chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.
About 5%-10% of those treated at her site had allergic conjunctivitis; most cases resolved with eye drops. So far, “it looks very safe but we need to have long-term data,” she added.
Dr. Simpson said that he was pleased to see the maintenance of therapeutic effects with no emergence of new side effects with the report of 52-week CHRONOS data in March at the American Academy of Dermatology annual meeting.
“We’re entering the era and the decade of atopic dermatitis,” he said. “Dermatologists should look out for many new topical and systemic therapies now that we’re uncovering and figuring out the pathophysiology of atopic dermatitis.”
Dupilumab, which costs $37,000 per year, is marketed by Regeneron and Sanofi. Studies in children and adolescents with AD are underway.
Dr. Guttman-Yassky has received funding from Regeneron for mechanistic studies and is working with most companies developing AD treatments. Dr. Simpson has received research grants from and serves as a consultant to Regeneron, as well as other pharmaceutical companies.
The approval of dupilumab, the first targeted biologic therapy approved in the United States for treatment of atopic dermatitis, provides a welcome, long-awaited alternative to currently available therapies for moderate to severe disease, according to two of the pivotal trial investigators.
In late March, the Food and Drug Administration approved dupilumab, a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, for the treatment of moderate to severe AD in adults “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.” It is administered subcutaneously, with an initial 600-mg dose, followed by 300 mg every other week, according to the prescribing information.
Dupilumab (Dupixent) was the second novel treatment approved for AD in less than 4 months – after years of no approvals of new therapies for this indication. In December, crisaborole ointment (Eucrisa) was approved for treatment of mild to moderate AD in patients aged 2 years and older. Crisaborole is a topical phosphodiesterase-4 inhibitor.
Dupilumab’s approval was based on three phase III studies of adults with moderate to severe AD: SOLO-1 and SOLO-2, which evaluated dupilumab as monotherapy, and the CHRONOS study, which compared dupilumab with topical corticosteroids to treatment with topical corticosteroids alone.
At 16 weeks in the SOLO trials, those treated with dupilumab had improvements in signs and symptoms of AD, including pruritus, anxiety and depression, and quality of life, compared with placebo. Almost 40% of those treated with dupilumab met the primary outcome – a score of clear or almost clear on the Investigator’s Global Assessment and a reduction of 2 points or more in that score from baseline – compared with 8%-10% of those on placebo (P less than .001). Injection-site reactions and conjunctivitis were more common among those treated with dupilumab (N Engl J Med. 2016;375:2335-48).
Emma Guttman-Yassky, MD, PhD, also an investigator in the SOLO 1 and SOLO 2 trials, said that prior to the approval, “we had nothing to treat our patients safely long term.”
“With dupilumab, because it’s specific, it provides the safety that we need,” while providing efficacy that is similar to or better than that of cyclosporine, with the caveat that dupilumab and cyclosporine have not been evaluated in a head-to-head study, Dr. Guttman-Yassky, professor and vice-chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.
About 5%-10% of those treated at her site had allergic conjunctivitis; most cases resolved with eye drops. So far, “it looks very safe but we need to have long-term data,” she added.
Dr. Simpson said that he was pleased to see the maintenance of therapeutic effects with no emergence of new side effects with the report of 52-week CHRONOS data in March at the American Academy of Dermatology annual meeting.
“We’re entering the era and the decade of atopic dermatitis,” he said. “Dermatologists should look out for many new topical and systemic therapies now that we’re uncovering and figuring out the pathophysiology of atopic dermatitis.”
Dupilumab, which costs $37,000 per year, is marketed by Regeneron and Sanofi. Studies in children and adolescents with AD are underway.
Dr. Guttman-Yassky has received funding from Regeneron for mechanistic studies and is working with most companies developing AD treatments. Dr. Simpson has received research grants from and serves as a consultant to Regeneron, as well as other pharmaceutical companies.
The approval of dupilumab, the first targeted biologic therapy approved in the United States for treatment of atopic dermatitis, provides a welcome, long-awaited alternative to currently available therapies for moderate to severe disease, according to two of the pivotal trial investigators.
In late March, the Food and Drug Administration approved dupilumab, a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, for the treatment of moderate to severe AD in adults “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.” It is administered subcutaneously, with an initial 600-mg dose, followed by 300 mg every other week, according to the prescribing information.
Dupilumab (Dupixent) was the second novel treatment approved for AD in less than 4 months – after years of no approvals of new therapies for this indication. In December, crisaborole ointment (Eucrisa) was approved for treatment of mild to moderate AD in patients aged 2 years and older. Crisaborole is a topical phosphodiesterase-4 inhibitor.
Dupilumab’s approval was based on three phase III studies of adults with moderate to severe AD: SOLO-1 and SOLO-2, which evaluated dupilumab as monotherapy, and the CHRONOS study, which compared dupilumab with topical corticosteroids to treatment with topical corticosteroids alone.
At 16 weeks in the SOLO trials, those treated with dupilumab had improvements in signs and symptoms of AD, including pruritus, anxiety and depression, and quality of life, compared with placebo. Almost 40% of those treated with dupilumab met the primary outcome – a score of clear or almost clear on the Investigator’s Global Assessment and a reduction of 2 points or more in that score from baseline – compared with 8%-10% of those on placebo (P less than .001). Injection-site reactions and conjunctivitis were more common among those treated with dupilumab (N Engl J Med. 2016;375:2335-48).
Emma Guttman-Yassky, MD, PhD, also an investigator in the SOLO 1 and SOLO 2 trials, said that prior to the approval, “we had nothing to treat our patients safely long term.”
“With dupilumab, because it’s specific, it provides the safety that we need,” while providing efficacy that is similar to or better than that of cyclosporine, with the caveat that dupilumab and cyclosporine have not been evaluated in a head-to-head study, Dr. Guttman-Yassky, professor and vice-chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, said in an interview.
About 5%-10% of those treated at her site had allergic conjunctivitis; most cases resolved with eye drops. So far, “it looks very safe but we need to have long-term data,” she added.
Dr. Simpson said that he was pleased to see the maintenance of therapeutic effects with no emergence of new side effects with the report of 52-week CHRONOS data in March at the American Academy of Dermatology annual meeting.
“We’re entering the era and the decade of atopic dermatitis,” he said. “Dermatologists should look out for many new topical and systemic therapies now that we’re uncovering and figuring out the pathophysiology of atopic dermatitis.”
Dupilumab, which costs $37,000 per year, is marketed by Regeneron and Sanofi. Studies in children and adolescents with AD are underway.
Dr. Guttman-Yassky has received funding from Regeneron for mechanistic studies and is working with most companies developing AD treatments. Dr. Simpson has received research grants from and serves as a consultant to Regeneron, as well as other pharmaceutical companies.