Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib

Combe, Bernard; Balsa, Alejandro; Sarzi‐Puttini, Piercarlo; Tony, Hans‐Peter; Torre, Inmaculada de la; Rogai, Veronica; Durand, Frédérick; Witt, Sarah; Zhong, Jinglin; Dougados, Maxime

doi:10.1136/annrheumdis-2018-214261

Cited by 11 publications

(4 citation statements)

References 5 publications

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“…The baricitinib clinical trials for RA did not exclude patients with any of the above-mentioned risk factors, except for recent comorbidities such as MI or stroke within 12 weeks, active or recent (within 30 days) serious infection, or malignant disease [ 33 ]. Clinical trials studying baricitinib in AD and AA also excluded patients with MI, stroke, or VTE events within 12 weeks of screening, active or recent (within 30 days) serious infection, or malignant disease, as well as those who had history of, or are considered at high risk for, VTE [ 34 , 35 ].…”

Section: Methodsmentioning

confidence: 99%

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

et al. 2023

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Section: Methodsmentioning

confidence: 99%

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

et al. 2023

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“…Extensive information on each of the studies has been previously published [ 18 ]. This analysis examines the incidence of ILD cases on patients exposed to baricitinib, further following on from a previous extensive safety report [ 19 ]. The clinical and safety databases were searched for the MedDRA narrow preferred terms within the Interstitial Lung Disease Standardised MedDRA Queries (SMQ).…”

Section: Methodsmentioning

confidence: 99%

Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials

et al. 2021

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Objectives: Interstitial lung disease (ILD) occurs in up to 30% of patients with rheumatoid arthritis (RA), resulting in increased morbidity and death in the absence of proven therapies. The aim of this study is to estimate the number of incident ILD cases reported through development studies with baricitinib in patients with RA. Methods: Estimates were based on 3770 patients with RA from eight randomized clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension study on baricitinib for which ILD was not an exclusion criterion with 12,358 patient-years of exposure (PYE).Results: Twenty-one non-infectious cases of ILD were reported with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 PYE. Of the 21 cases, six were reported as serious and 15 as non-serious resulting in an incidence rate of 0.05 per 100 PYE and 0.12 per 100 PYE, respectively. There were also 11 cases caused by an infectious agent: seven serious (IR: 0.06 per 100 PYE) and four non-serious cases (IR: 0.03 per 100 PYE). Conclusions: The findings of this analysis in patients with RA treated with baricitinib are consistent with a low risk to develop non-infectious ILD during baricitinib treatment, similar to that observed with other Janus kinase inhibitors.

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“…По данным анализа (post hoc) РКИ RA-BEAM и RA-BUILD, демографические факторы, включая пол, возраст, курение, длительность РА, индекс массы тела, а также серопозитивность по РФ и АЦЦП, не оказывали достоверного влияния на эффективность и безопасность терапии БАРИ при РА [72]. Особенно важные данные получены при анализе (post hoc) эффективности и безопасности БАРИ в зависимости от коморбидных заболеваний [73], а именно: депрессии, остеопороза, болезней печени, сердечно-сосудистой системы, легких, которые, как уже отмечалось, характерны для РА. Всего было проанализировано 1648 пациентов, включенных в основные РКИ БАРИ, из которых 803 получали БАРИ 4 мг, 882 -ПЛ, а в качестве «фоновой» терапии -МТ.…”

Section: коморбидностьunclassified

Baricitinib: New Pharmacotherapy Options for Rheumatoid Arthritis and Other Immune-Mediated Inflammatory Rheumatic Diseases

Nasonov

Лила

2020

Naučno-praktičeskaâ revmatologiâ

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Deciphering the mechanisms of the pathogenesis of immune-mediated inflammatory rheumatic diseases (IMIRDs) in conjunction with designing a wide range of biological agents is one of the major medical advances in the 21st century. A new promising area of pharmacotherapy for IMIRDs is associated with the design of the so-called targeted oral medications that primarily include Janus kinase (JAK) inhibitors. The review presents new data on the efficacy and safety of the new JAK inhibitor baricitinib in treating rheumatoid arthritis and other IMIRDs.

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Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib

Cited by 11 publications

References 5 publications

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

Baricitinib and the Risk of Incident Interstitial Lung Disease: A Descriptive Clinical Case Report from Clinical Trials

Baricitinib: New Pharmacotherapy Options for Rheumatoid Arthritis and Other Immune-Mediated Inflammatory Rheumatic Diseases

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