Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids

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Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids. / Silverberg, Jonathan I; Armstrong, April; Blauvelt, Andrew; Reich, Kristian.

In: AM J CLIN DERMATOL, Vol. 24, No. 6, 11.2023, p. 913-925.

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@article{1aeb4df93d0a4fb987c5e9235fdcaa66,
title = "Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids",
abstract = "Atopic dermatitis (AD) is a chronic inflammatory disease requiring efficacious and safe long-term therapy. Several new systemic treatments have recently been approved for use in patients with moderate to severe AD. However, head-to-head comparisons have not been conducted for all the currently available treatments for AD. Multiple network meta-analyses have compared efficacy of these different therapies during the initial 16-week treatment period, but not beyond week 16. Therefore, understanding the differences in key trial design and statistical methods is essential for evaluating long-term efficacy, making cross-trial comparisons, and informing treatment decisions. This focused narrative review provides an overview of data and trial methodology to guide clinicians in evaluating longer-term efficacy and safety of currently approved systemic treatments for patients with AD. We discuss important elements of longer-term trial designs and statistical analysis strategies that should be considered based on our experience as clinical trialists. In addition, a summary of key efficacy results of published, longer-term, phase III clinical trials of US Food and Drug Administration-approved, novel systemic treatments (i.e., dupilumab, tralokinumab, abrocitinib, and upadacitinib) is provided, including the design and data handling methods used. Long-term safety considerations and differences in the time-effect and safety profiles of various medications are also noted to help inform clinical decisions for individual patients. Overall, the findings of these trials support efficacy in long-term treatment with novel systemic agents for patients with AD.",
keywords = "Humans, Administration, Cutaneous, Adrenal Cortex Hormones/adverse effects, Dermatitis, Atopic/diagnosis, Dermatologic Agents/adverse effects, Severity of Illness Index, Treatment Outcome",
author = "Silverberg, {Jonathan I} and April Armstrong and Andrew Blauvelt and Kristian Reich",
note = "{\textcopyright} 2023. The Author(s).",
year = "2023",
month = nov,
doi = "10.1007/s40257-023-00809-0",
language = "English",
volume = "24",
pages = "913--925",
journal = "AM J CLIN DERMATOL",
issn = "1175-0561",
publisher = "Adis International Ltd",
number = "6",

}

RIS

TY - JOUR

T1 - Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids

AU - Silverberg, Jonathan I

AU - Armstrong, April

AU - Blauvelt, Andrew

AU - Reich, Kristian

N1 - © 2023. The Author(s).

PY - 2023/11

Y1 - 2023/11

N2 - Atopic dermatitis (AD) is a chronic inflammatory disease requiring efficacious and safe long-term therapy. Several new systemic treatments have recently been approved for use in patients with moderate to severe AD. However, head-to-head comparisons have not been conducted for all the currently available treatments for AD. Multiple network meta-analyses have compared efficacy of these different therapies during the initial 16-week treatment period, but not beyond week 16. Therefore, understanding the differences in key trial design and statistical methods is essential for evaluating long-term efficacy, making cross-trial comparisons, and informing treatment decisions. This focused narrative review provides an overview of data and trial methodology to guide clinicians in evaluating longer-term efficacy and safety of currently approved systemic treatments for patients with AD. We discuss important elements of longer-term trial designs and statistical analysis strategies that should be considered based on our experience as clinical trialists. In addition, a summary of key efficacy results of published, longer-term, phase III clinical trials of US Food and Drug Administration-approved, novel systemic treatments (i.e., dupilumab, tralokinumab, abrocitinib, and upadacitinib) is provided, including the design and data handling methods used. Long-term safety considerations and differences in the time-effect and safety profiles of various medications are also noted to help inform clinical decisions for individual patients. Overall, the findings of these trials support efficacy in long-term treatment with novel systemic agents for patients with AD.

AB - Atopic dermatitis (AD) is a chronic inflammatory disease requiring efficacious and safe long-term therapy. Several new systemic treatments have recently been approved for use in patients with moderate to severe AD. However, head-to-head comparisons have not been conducted for all the currently available treatments for AD. Multiple network meta-analyses have compared efficacy of these different therapies during the initial 16-week treatment period, but not beyond week 16. Therefore, understanding the differences in key trial design and statistical methods is essential for evaluating long-term efficacy, making cross-trial comparisons, and informing treatment decisions. This focused narrative review provides an overview of data and trial methodology to guide clinicians in evaluating longer-term efficacy and safety of currently approved systemic treatments for patients with AD. We discuss important elements of longer-term trial designs and statistical analysis strategies that should be considered based on our experience as clinical trialists. In addition, a summary of key efficacy results of published, longer-term, phase III clinical trials of US Food and Drug Administration-approved, novel systemic treatments (i.e., dupilumab, tralokinumab, abrocitinib, and upadacitinib) is provided, including the design and data handling methods used. Long-term safety considerations and differences in the time-effect and safety profiles of various medications are also noted to help inform clinical decisions for individual patients. Overall, the findings of these trials support efficacy in long-term treatment with novel systemic agents for patients with AD.

KW - Humans

KW - Administration, Cutaneous

KW - Adrenal Cortex Hormones/adverse effects

KW - Dermatitis, Atopic/diagnosis

KW - Dermatologic Agents/adverse effects

KW - Severity of Illness Index

KW - Treatment Outcome

U2 - 10.1007/s40257-023-00809-0

DO - 10.1007/s40257-023-00809-0

M3 - SCORING: Review article

C2 - 37695504

VL - 24

SP - 913

EP - 925

JO - AM J CLIN DERMATOL

JF - AM J CLIN DERMATOL

SN - 1175-0561

IS - 6

ER -