Baricitinib in adult patients with moderate-to-severe atopic dermatitis

A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study

Emma Guttman-Yassky, Jonathan I. Silverberg, Osamu Nemoto, Seth B. Forman, August Wilke, Randy Prescilla, Amparo de la Peña, Fabio P. Nunes, Jonathan Janes, Margaret Gamalo, David Donley, Jim Paik, Amy M. DeLozier, Brian J. Nickoloff, Eric Simpson

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Background: Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. Objectives: The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). Methods: In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. Results: Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P =.027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). Limitations: A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. Conclusions: Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.

Original languageEnglish (US)
Pages (from-to)913-921.e9
JournalJournal of the American Academy of Dermatology
Volume80
Issue number4
DOIs
StatePublished - Apr 1 2019

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Atopic Dermatitis
Placebos
Adrenal Cortex Hormones
Pruritus
Random Allocation
baricitinib
Janus Kinase 1
Janus Kinase 2
Aptitude
Eczema
Patient Safety
Sleep
Cytokines
Inflammation
Safety

Keywords

  • atopic dermatitis
  • baricitinib
  • EASI
  • JAK-STAT signaling
  • phase 2
  • pruritus
  • SCORAD
  • topical corticosteroids

ASJC Scopus subject areas

  • Dermatology

Cite this

Baricitinib in adult patients with moderate-to-severe atopic dermatitis : A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. / Guttman-Yassky, Emma; Silverberg, Jonathan I.; Nemoto, Osamu; Forman, Seth B.; Wilke, August; Prescilla, Randy; de la Peña, Amparo; Nunes, Fabio P.; Janes, Jonathan; Gamalo, Margaret; Donley, David; Paik, Jim; DeLozier, Amy M.; Nickoloff, Brian J.; Simpson, Eric.

In: Journal of the American Academy of Dermatology, Vol. 80, No. 4, 01.04.2019, p. 913-921.e9.

Research output: Contribution to journalArticle

Guttman-Yassky, E, Silverberg, JI, Nemoto, O, Forman, SB, Wilke, A, Prescilla, R, de la Peña, A, Nunes, FP, Janes, J, Gamalo, M, Donley, D, Paik, J, DeLozier, AM, Nickoloff, BJ & Simpson, E 2019, 'Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study', Journal of the American Academy of Dermatology, vol. 80, no. 4, pp. 913-921.e9. https://doi.org/10.1016/j.jaad.2018.01.018
Guttman-Yassky, Emma ; Silverberg, Jonathan I. ; Nemoto, Osamu ; Forman, Seth B. ; Wilke, August ; Prescilla, Randy ; de la Peña, Amparo ; Nunes, Fabio P. ; Janes, Jonathan ; Gamalo, Margaret ; Donley, David ; Paik, Jim ; DeLozier, Amy M. ; Nickoloff, Brian J. ; Simpson, Eric. / Baricitinib in adult patients with moderate-to-severe atopic dermatitis : A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. In: Journal of the American Academy of Dermatology. 2019 ; Vol. 80, No. 4. pp. 913-921.e9.
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abstract = "Background: Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. Objectives: The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). Methods: In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50{\%} reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. Results: Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61{\%} vs 37{\%} [P =.027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49{\%}), 17 of those receiving 2 mg of baricitinib (46{\%}), and 27 of those receiving 4 mg of baricitinib (71{\%}). Limitations: A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. Conclusions: Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.",
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AU - Silverberg, Jonathan I.

AU - Nemoto, Osamu

AU - Forman, Seth B.

AU - Wilke, August

AU - Prescilla, Randy

AU - de la Peña, Amparo

AU - Nunes, Fabio P.

AU - Janes, Jonathan

AU - Gamalo, Margaret

AU - Donley, David

AU - Paik, Jim

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N2 - Background: Baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, modulates proinflammatory cytokine signaling. Objectives: The efficacy and safety of baricitinib were evaluated in patients with moderate-to-severe atopic dermatitis (AD). Methods: In this phase 2, randomized, double-blind, placebo-controlled study, 124 patients with moderate-to-severe AD applied topical corticosteroids (TCSs) for 4 weeks before randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks. Use of TCSs was permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo. Results: Significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37% [P =.027]) at 16 weeks. The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%). Limitations: A TCS standardization period before randomization reduced disease severity, limiting the ability to compare results with those of baricitinib monotherapy. Longer studies are required to confirm baricitinib's efficacy and safety in patients with AD. Conclusions: Baricitinib used with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD.

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