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Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.
J Am Acad Dermatol. 2019 Apr; 80(4):913-921.e9.JA

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.

Authors+Show Affiliations

Department of Dermatology, Icahn School of Medicine at the Mount Sinai Medical Center, New York, New York; Laboratory for Inflammatory Skin Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, New York. Electronic address: Emma.Guttman@mountsinai.org.Department of Dermatology, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Department of Preventive Medicine, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Department of Medical Social Sciences, Feinberg School of Medicine at Northwestern University, Chicago, Illinois; Northwestern Medicine Multidisciplinary Eczema Center, Chicago, Illinois.Department of Dermatology, Sapporo Skin Clinic, Hokkaido, Japan.Forward Clinical Trials, Inc, Tampa, Florida.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.EMB Statistical Solutions, LLC, Overland Park, Kansas.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Eli Lilly and Company, Indianapolis, Indiana.Department of Dermatology, Oregon Health and Science University, Portland, Oregon.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29410014

Citation

Guttman-Yassky, Emma, et al. "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, 2019, pp. 913-921.e9.
Guttman-Yassky E, Silverberg JI, Nemoto O, et al. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. J Am Acad Dermatol. 2019;80(4):913-921.e9.
Guttman-Yassky, E., Silverberg, J. I., Nemoto, O., Forman, S. B., Wilke, A., Prescilla, R., de la Peña, A., Nunes, F. P., Janes, J., Gamalo, M., Donley, D., Paik, J., DeLozier, A. M., Nickoloff, B. J., & Simpson, E. L. (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, 80(4), 913-e9. https://doi.org/10.1016/j.jaad.2018.01.018
Guttman-Yassky E, et al. Baricitinib in Adult Patients With Moderate-to-severe Atopic Dermatitis: a Phase 2 Parallel, Double-blinded, Randomized Placebo-controlled Multiple-dose Study. J Am Acad Dermatol. 2019;80(4):913-921.e9. PubMed PMID: 29410014.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. AU - Guttman-Yassky,Emma, 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, AU - DeLozier,Amy M, AU - Nickoloff,Brian J, AU - Simpson,Eric L, Y1 - 2018/02/02/ PY - 2017/10/12/received PY - 2017/12/20/revised PY - 2018/01/13/accepted PY - 2018/2/8/pubmed PY - 2019/4/23/medline PY - 2018/2/8/entrez KW - EASI KW - JAK-STAT signaling KW - SCORAD KW - atopic dermatitis KW - baricitinib KW - phase 2 KW - pruritus KW - topical corticosteroids SP - 913 EP - 921.e9 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 80 IS - 4 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/29410014/Baricitinib_in_adult_patients_with_moderate_to_severe_atopic_dermatitis:_A_phase_2_parallel_double_blinded_randomized_placebo_controlled_multiple_dose_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(18)30129-4 DB - PRIME DP - Unbound Medicine ER -