Tags

Type your tag names separated by a space and hit enter

Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials.
Am J Clin Dermatol. 2021 May; 22(3):395-405.AJ

Abstract

BACKGROUND

Baricitinib, a selective Janus kinase 1/Janus kinase 2 inhibitor, is indicated in the European Union and Japan for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

OBJECTIVE

The objective of this study was to evaluate the safety of baricitinib 2 mg in the AD clinical program.

METHODS

Six double-blind, randomized, placebo-controlled studies, and two long-term extension studies were summarized in two datasets. Placebo comparison was based on six 16-week studies with baricitinib 2 mg. All-bari-2-mg-AD included patients who received baricitinib 2 mg at any time during the eight studies.

RESULTS

In total, 1598 patients received once-daily baricitinib 2 mg for 1434.2 patient-years of exposure (median 330 days/maximum 2.4 years). Treatment-emergent adverse events were higher for baricitinib 2 mg (57.9%) vs placebo (51.6%). Serious adverse events, serious infections, and opportunistic infections were low in frequency and similar between baricitinib 2 mg and placebo. There were no malignancies, gastrointestinal perforations, or major adverse cardiovascular events with baricitinib 2 mg in the placebo-controlled period. Herpes simplex (cluster) was higher for baricitinib 2 mg (3.8%) vs placebo (2.8%); rates decreased with extended 2 mg exposure. In All-bari-2-mg-AD, there were five malignancies other than non-melanoma skin cancer, two major adverse cardiovascular events, one peripheral venous thrombosis, one arterial thrombosis, and no pulmonary embolisms, deep vein thromboses, or deaths.

CONCLUSIONS

This integrated analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib 2 mg. Longer exposure to treatment is required to evaluate risks of malignancies and major adverse cardiovascular events.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov identifiers: NCT02576938 (first posted 15 October, 2015); NCT03334396 (7 November, 2017); NCT03334422 (7 November, 2017); NCT03428100 (9 February, 2018); NCT03435081 (15 February, 2018); NCT03733301 (7 November, 2018); NCT03334435 (7 November, 2017); NCT03559270 (18 June, 2018).

Authors+Show Affiliations

Department of Dermatology, Yale School of Medicine, 333 Cedar Street, LCI 501, PO Box 208059, New Haven, CT, 06510, USA. brett.king@yale.edu.Innovaderm Research, Montreal, QC, Canada.Sanova Dermatology, Pflugerville, TX, USA.Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA.Eli Lilly and Company, Indianapolis, IN, USA.Eli Lilly and Company, Indianapolis, IN, USA.Eli Lilly and Company, Indianapolis, IN, USA.Eli Lilly and Company, Indianapolis, IN, USA.Eli Lilly and Company, Indianapolis, IN, USA.Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.

Pub Type(s)

Journal Article
Video-Audio Media

Language

eng

PubMed ID

33826132

Citation

King, Brett, et al. "Extended Safety Analysis of Baricitinib 2 Mg in Adult Patients With Atopic Dermatitis: an Integrated Analysis From Eight Randomized Clinical Trials." American Journal of Clinical Dermatology, vol. 22, no. 3, 2021, pp. 395-405.
King B, Maari C, Lain E, et al. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021;22(3):395-405.
King, B., Maari, C., Lain, E., Silverberg, J. I., Issa, M., Holzwarth, K., Brinker, D., Cardillo, T., Nunes, F. P., & Simpson, E. L. (2021). Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. American Journal of Clinical Dermatology, 22(3), 395-405. https://doi.org/10.1007/s40257-021-00602-x
King B, et al. Extended Safety Analysis of Baricitinib 2 Mg in Adult Patients With Atopic Dermatitis: an Integrated Analysis From Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021;22(3):395-405. PubMed PMID: 33826132.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. AU - King,Brett, AU - Maari,Catherine, AU - Lain,Edward, AU - Silverberg,Jonathan I, AU - Issa,Maher, AU - Holzwarth,Katrin, AU - Brinker,Dennis, AU - Cardillo,Tracy, AU - Nunes,Fabio P, AU - Simpson,Eric L, Y1 - 2021/04/07/ PY - 2021/03/26/accepted PY - 2021/4/8/pubmed PY - 2021/8/24/medline PY - 2021/4/7/entrez SP - 395 EP - 405 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 22 IS - 3 N2 - BACKGROUND: Baricitinib, a selective Janus kinase 1/Janus kinase 2 inhibitor, is indicated in the European Union and Japan for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. OBJECTIVE: The objective of this study was to evaluate the safety of baricitinib 2 mg in the AD clinical program. METHODS: Six double-blind, randomized, placebo-controlled studies, and two long-term extension studies were summarized in two datasets. Placebo comparison was based on six 16-week studies with baricitinib 2 mg. All-bari-2-mg-AD included patients who received baricitinib 2 mg at any time during the eight studies. RESULTS: In total, 1598 patients received once-daily baricitinib 2 mg for 1434.2 patient-years of exposure (median 330 days/maximum 2.4 years). Treatment-emergent adverse events were higher for baricitinib 2 mg (57.9%) vs placebo (51.6%). Serious adverse events, serious infections, and opportunistic infections were low in frequency and similar between baricitinib 2 mg and placebo. There were no malignancies, gastrointestinal perforations, or major adverse cardiovascular events with baricitinib 2 mg in the placebo-controlled period. Herpes simplex (cluster) was higher for baricitinib 2 mg (3.8%) vs placebo (2.8%); rates decreased with extended 2 mg exposure. In All-bari-2-mg-AD, there were five malignancies other than non-melanoma skin cancer, two major adverse cardiovascular events, one peripheral venous thrombosis, one arterial thrombosis, and no pulmonary embolisms, deep vein thromboses, or deaths. CONCLUSIONS: This integrated analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib 2 mg. Longer exposure to treatment is required to evaluate risks of malignancies and major adverse cardiovascular events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02576938 (first posted 15 October, 2015); NCT03334396 (7 November, 2017); NCT03334422 (7 November, 2017); NCT03428100 (9 February, 2018); NCT03435081 (15 February, 2018); NCT03733301 (7 November, 2018); NCT03334435 (7 November, 2017); NCT03559270 (18 June, 2018). SN - 1179-1888 UR - https://www.unboundmedicine.com/medline/citation/33826132/Extended_Safety_Analysis_of_Baricitinib_2_mg_in_Adult_Patients_with_Atopic_Dermatitis:_An_Integrated_Analysis_from_Eight_Randomized_Clinical_Trials_ L2 - https://dx.doi.org/10.1007/s40257-021-00602-x DB - PRIME DP - Unbound Medicine ER -