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Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials

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Harvard

Bieber, T, Thyssen, JP, Reich, K, Simpson, EL, Katoh, N, Torrelo, A, De Bruin-Weller, M, Thaci, D, Bissonnette, R, Gooderham, M, Weisman, J, Nunes, F, Brinker, D, Issa, M, Holzwarth, K, Gamalo, M, Riedl, E & Janes, J 2021, 'Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials', Journal of the European Academy of Dermatology and Venereology : JEADV, vol. 35, no. 2, pp. 476-485. https://doi.org/10.1111/jdv.16948

APA

Bieber, T., Thyssen, J. P., Reich, K., Simpson, E. L., Katoh, N., Torrelo, A., De Bruin-Weller, M., Thaci, D., Bissonnette, R., Gooderham, M., Weisman, J., Nunes, F., Brinker, D., Issa, M., Holzwarth, K., Gamalo, M., Riedl, E., & Janes, J. (2021). Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. Journal of the European Academy of Dermatology and Venereology : JEADV, 35(2), 476-485. https://doi.org/10.1111/jdv.16948

CBE

Bieber T, Thyssen JP, Reich K, Simpson EL, Katoh N, Torrelo A, De Bruin-Weller M, Thaci D, Bissonnette R, Gooderham M, Weisman J, Nunes F, Brinker D, Issa M, Holzwarth K, Gamalo M, Riedl E, Janes J. 2021. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. Journal of the European Academy of Dermatology and Venereology : JEADV. 35(2):476-485. https://doi.org/10.1111/jdv.16948

MLA

Vancouver

Author

Bieber, T ; Thyssen, J P ; Reich, K ; Simpson, E L ; Katoh, N ; Torrelo, A ; De Bruin-Weller, M ; Thaci, D ; Bissonnette, R ; Gooderham, M ; Weisman, J ; Nunes, F ; Brinker, D ; Issa, M ; Holzwarth, K ; Gamalo, M ; Riedl, E ; Janes, J. / Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. In: Journal of the European Academy of Dermatology and Venereology : JEADV. 2021 ; Vol. 35, No. 2. pp. 476-485.

Bibtex

@article{8137e12c5d8b47e2adb53cc3559c8490,
title = "Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials",
abstract = "BACKGROUND: Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1/JAK2, is in late-stage development for adult patients with moderate-to-severe AD.OBJECTIVE: To report pooled safety data for baricitinib in patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies.METHODS: This analysis included patient-level safety data from six double-blinded, randomized, placebo-controlled studies (one phase 2 and five phase 3), one double-blinded, randomized, LTE study and one open-label LTE study, reported in three data sets: placebo-controlled, 2-mg - 4-mg extended and All-bari AD. Safety outcomes include treatment-emergent adverse events, adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.RESULTS: Data were collected for 2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days). The frequency of serious infections, opportunistic infections and conjunctival disorders was low and similar between treatment groups in the placebo-controlled period. The most common serious infections were eczema herpeticum [n = 11, incidence rates (IR) = 0.5], cellulitis (n = 6, IR = 0.3) and pneumonia (n = 3, IR = 0.1). There were four opportunistic infections (IR = 0.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients. Frequency of herpes simplex was higher in the 4-mg group (6.1%) vs. the 2-mg (3.6%) and placebo group (2.7%); IRs in the extended data set (2-mg IR = 9.6; 4-mg IR = 14.5) were lower vs. the placebo-controlled data set (2-mg IR = 12.4; 4-mg IR = 21.3). In the All-bari AD data set, there were two positively adjudicated major adverse cardiovascular events (2-mg group): two venous thrombosis events (4-mg group) and one death.CONCLUSION: This integrated safety analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib.",
keywords = "Adult, Azetidines, Dermatitis, Atopic/drug therapy, Double-Blind Method, Humans, Pharmaceutical Preparations, Purines, Pyrazoles, Randomized Controlled Trials as Topic, Sulfonamides, Treatment Outcome",
author = "T Bieber and Thyssen, {J P} and K Reich and Simpson, {E L} and N Katoh and A Torrelo and {De Bruin-Weller}, M and D Thaci and R Bissonnette and M Gooderham and J Weisman and F Nunes and D Brinker and M Issa and K Holzwarth and M Gamalo and E Riedl and J Janes",
note = "{\textcopyright} 2020 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.",
year = "2021",
month = feb,
doi = "10.1111/jdv.16948",
language = "English",
volume = "35",
pages = "476--485",
journal = "Journal of the European Academy of Dermatology and Venereology",
issn = "0926-9959",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "2",

}

RIS

TY - JOUR

T1 - Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials

AU - Bieber, T

AU - Thyssen, J P

AU - Reich, K

AU - Simpson, E L

AU - Katoh, N

AU - Torrelo, A

AU - De Bruin-Weller, M

AU - Thaci, D

AU - Bissonnette, R

AU - Gooderham, M

AU - Weisman, J

AU - Nunes, F

AU - Brinker, D

AU - Issa, M

AU - Holzwarth, K

AU - Gamalo, M

AU - Riedl, E

AU - Janes, J

N1 - © 2020 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

PY - 2021/2

Y1 - 2021/2

N2 - BACKGROUND: Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1/JAK2, is in late-stage development for adult patients with moderate-to-severe AD.OBJECTIVE: To report pooled safety data for baricitinib in patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies.METHODS: This analysis included patient-level safety data from six double-blinded, randomized, placebo-controlled studies (one phase 2 and five phase 3), one double-blinded, randomized, LTE study and one open-label LTE study, reported in three data sets: placebo-controlled, 2-mg - 4-mg extended and All-bari AD. Safety outcomes include treatment-emergent adverse events, adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.RESULTS: Data were collected for 2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days). The frequency of serious infections, opportunistic infections and conjunctival disorders was low and similar between treatment groups in the placebo-controlled period. The most common serious infections were eczema herpeticum [n = 11, incidence rates (IR) = 0.5], cellulitis (n = 6, IR = 0.3) and pneumonia (n = 3, IR = 0.1). There were four opportunistic infections (IR = 0.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients. Frequency of herpes simplex was higher in the 4-mg group (6.1%) vs. the 2-mg (3.6%) and placebo group (2.7%); IRs in the extended data set (2-mg IR = 9.6; 4-mg IR = 14.5) were lower vs. the placebo-controlled data set (2-mg IR = 12.4; 4-mg IR = 21.3). In the All-bari AD data set, there were two positively adjudicated major adverse cardiovascular events (2-mg group): two venous thrombosis events (4-mg group) and one death.CONCLUSION: This integrated safety analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib.

AB - BACKGROUND: Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1/JAK2, is in late-stage development for adult patients with moderate-to-severe AD.OBJECTIVE: To report pooled safety data for baricitinib in patients with moderate-to-severe AD in the clinical development program including long-term extension (LTE) studies.METHODS: This analysis included patient-level safety data from six double-blinded, randomized, placebo-controlled studies (one phase 2 and five phase 3), one double-blinded, randomized, LTE study and one open-label LTE study, reported in three data sets: placebo-controlled, 2-mg - 4-mg extended and All-bari AD. Safety outcomes include treatment-emergent adverse events, adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.RESULTS: Data were collected for 2531 patients who were given baricitinib for 2247 patient-years (median duration 310 days). The frequency of serious infections, opportunistic infections and conjunctival disorders was low and similar between treatment groups in the placebo-controlled period. The most common serious infections were eczema herpeticum [n = 11, incidence rates (IR) = 0.5], cellulitis (n = 6, IR = 0.3) and pneumonia (n = 3, IR = 0.1). There were four opportunistic infections (IR = 0.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events or tuberculosis were reported in the placebo-controlled period in baricitinib-treated patients. Frequency of herpes simplex was higher in the 4-mg group (6.1%) vs. the 2-mg (3.6%) and placebo group (2.7%); IRs in the extended data set (2-mg IR = 9.6; 4-mg IR = 14.5) were lower vs. the placebo-controlled data set (2-mg IR = 12.4; 4-mg IR = 21.3). In the All-bari AD data set, there were two positively adjudicated major adverse cardiovascular events (2-mg group): two venous thrombosis events (4-mg group) and one death.CONCLUSION: This integrated safety analysis in patients with moderate-to-severe AD confirms the established safety profile of baricitinib.

KW - Adult

KW - Azetidines

KW - Dermatitis, Atopic/drug therapy

KW - Double-Blind Method

KW - Humans

KW - Pharmaceutical Preparations

KW - Purines

KW - Pyrazoles

KW - Randomized Controlled Trials as Topic

KW - Sulfonamides

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85092115089&partnerID=8YFLogxK

U2 - 10.1111/jdv.16948

DO - 10.1111/jdv.16948

M3 - Journal article

C2 - 32926462

VL - 35

SP - 476

EP - 485

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 2

ER -

ID: 67626209