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TOPLINE:
Over 5 years, dupilumab demonstrated acceptable safety and sustained efficacy, with significant improvements in the signs and symptoms of AD, in the treatment of moderate to severe atopic dermatitis (AD).
METHODOLOGY:
- The phase 3 multinational LIBERTY AD open-label extension study evaluated the safety and efficacy of dupilumab in 2677 adults with moderate to severe AD who had previously participated in dupilumab trials over 5 years; 334 patients (12.5%) completed treatment up to 5 years.
- Patients started with subcutaneous dupilumab, initially dosed weekly after a loading dose, then every 2 weeks in 2019.
- The primary outcomes were the incidence and rate of treatment-emergent adverse events (TEAEs).
TAKEAWAY:
- Overall, 14,717 TEAEs were reported over 5 years. The exposure-adjusted incidence rate decreased over time and was 252.48 events per 100 patient-years.
- The most common TEAEs were nasopharyngitis (28.9%), worsening AD (16.7%), upper respiratory tract infection (13.6%), conjunctivitis (10.3%), allergic conjunctivitis (9%), headache (8.1%), oral herpes (7.5%), and injection-site reactions (5.2%).
- Serious and severe TEAE rates were 10.6% and 10.0%, respectively. Exposure-adjusted incidence rates were 6.66 and 6.71 events per 100 patient-years, respectively.
- At week 260, 67.5% of patients had achieved clear or almost clear skin according to the Investigator’s Global Assessment, and 88.9% experienced a 75% or greater improvement in the Eczema Area and Severity Index.
IN PRACTICE:
“Safety and efficacy results from up to 5 years of dupilumab treatment in the LIBERTY AD open-label extension study support dupilumab as a continuous long-term treatment for adults with moderate to severe AD,” the authors concluded.
SOURCE:
The study was led by Lisa A. Beck, MD, University of Rochester, Rochester, New York, and was published online in JAMA Dermatology.
LIMITATIONS:
Study limitations included the absence of a placebo arm and treatment interruptions stemming from protocol changes. The number of patients who received biweekly doses was small. The early conclusion of the trial by the sponsor because of regulatory approval also resulted in a lower number of patients at later stages.
DISCLOSURES:
This study was funded by dupilumab manufacturers Sanofi and Regeneron Pharmaceuticals. Several authors declared ties with various pharmaceutical companies including Sanofi and Regeneron, and several authors were employees of Sanofi or Regeneron. No disclosures were reported by other authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Over 5 years, dupilumab demonstrated acceptable safety and sustained efficacy, with significant improvements in the signs and symptoms of AD, in the treatment of moderate to severe atopic dermatitis (AD).
METHODOLOGY:
- The phase 3 multinational LIBERTY AD open-label extension study evaluated the safety and efficacy of dupilumab in 2677 adults with moderate to severe AD who had previously participated in dupilumab trials over 5 years; 334 patients (12.5%) completed treatment up to 5 years.
- Patients started with subcutaneous dupilumab, initially dosed weekly after a loading dose, then every 2 weeks in 2019.
- The primary outcomes were the incidence and rate of treatment-emergent adverse events (TEAEs).
TAKEAWAY:
- Overall, 14,717 TEAEs were reported over 5 years. The exposure-adjusted incidence rate decreased over time and was 252.48 events per 100 patient-years.
- The most common TEAEs were nasopharyngitis (28.9%), worsening AD (16.7%), upper respiratory tract infection (13.6%), conjunctivitis (10.3%), allergic conjunctivitis (9%), headache (8.1%), oral herpes (7.5%), and injection-site reactions (5.2%).
- Serious and severe TEAE rates were 10.6% and 10.0%, respectively. Exposure-adjusted incidence rates were 6.66 and 6.71 events per 100 patient-years, respectively.
- At week 260, 67.5% of patients had achieved clear or almost clear skin according to the Investigator’s Global Assessment, and 88.9% experienced a 75% or greater improvement in the Eczema Area and Severity Index.
IN PRACTICE:
“Safety and efficacy results from up to 5 years of dupilumab treatment in the LIBERTY AD open-label extension study support dupilumab as a continuous long-term treatment for adults with moderate to severe AD,” the authors concluded.
SOURCE:
The study was led by Lisa A. Beck, MD, University of Rochester, Rochester, New York, and was published online in JAMA Dermatology.
LIMITATIONS:
Study limitations included the absence of a placebo arm and treatment interruptions stemming from protocol changes. The number of patients who received biweekly doses was small. The early conclusion of the trial by the sponsor because of regulatory approval also resulted in a lower number of patients at later stages.
DISCLOSURES:
This study was funded by dupilumab manufacturers Sanofi and Regeneron Pharmaceuticals. Several authors declared ties with various pharmaceutical companies including Sanofi and Regeneron, and several authors were employees of Sanofi or Regeneron. No disclosures were reported by other authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Over 5 years, dupilumab demonstrated acceptable safety and sustained efficacy, with significant improvements in the signs and symptoms of AD, in the treatment of moderate to severe atopic dermatitis (AD).
METHODOLOGY:
- The phase 3 multinational LIBERTY AD open-label extension study evaluated the safety and efficacy of dupilumab in 2677 adults with moderate to severe AD who had previously participated in dupilumab trials over 5 years; 334 patients (12.5%) completed treatment up to 5 years.
- Patients started with subcutaneous dupilumab, initially dosed weekly after a loading dose, then every 2 weeks in 2019.
- The primary outcomes were the incidence and rate of treatment-emergent adverse events (TEAEs).
TAKEAWAY:
- Overall, 14,717 TEAEs were reported over 5 years. The exposure-adjusted incidence rate decreased over time and was 252.48 events per 100 patient-years.
- The most common TEAEs were nasopharyngitis (28.9%), worsening AD (16.7%), upper respiratory tract infection (13.6%), conjunctivitis (10.3%), allergic conjunctivitis (9%), headache (8.1%), oral herpes (7.5%), and injection-site reactions (5.2%).
- Serious and severe TEAE rates were 10.6% and 10.0%, respectively. Exposure-adjusted incidence rates were 6.66 and 6.71 events per 100 patient-years, respectively.
- At week 260, 67.5% of patients had achieved clear or almost clear skin according to the Investigator’s Global Assessment, and 88.9% experienced a 75% or greater improvement in the Eczema Area and Severity Index.
IN PRACTICE:
“Safety and efficacy results from up to 5 years of dupilumab treatment in the LIBERTY AD open-label extension study support dupilumab as a continuous long-term treatment for adults with moderate to severe AD,” the authors concluded.
SOURCE:
The study was led by Lisa A. Beck, MD, University of Rochester, Rochester, New York, and was published online in JAMA Dermatology.
LIMITATIONS:
Study limitations included the absence of a placebo arm and treatment interruptions stemming from protocol changes. The number of patients who received biweekly doses was small. The early conclusion of the trial by the sponsor because of regulatory approval also resulted in a lower number of patients at later stages.
DISCLOSURES:
This study was funded by dupilumab manufacturers Sanofi and Regeneron Pharmaceuticals. Several authors declared ties with various pharmaceutical companies including Sanofi and Regeneron, and several authors were employees of Sanofi or Regeneron. No disclosures were reported by other authors.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.