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Safety of baricitinib for the treatment of atopic dermatitis over a median of 1.6 years and up to 3.9 years of treatment: an updated integrated analysis of eight clinical trials.
Bieber, Thomas; Katoh, Norito; Simpson, Eric L; de Bruin-Weller, Marjolein; Thaçi, Diamant; Torrelo, Antonio; Sontag, Angelina; Grond, Susanne; Issa, Maher; Lu, Xiaoyu; Cardillo, Tracy; Holzwarth, Katrin; Thyssen, Jacob P.
Afiliación
  • Bieber T; Department of Dermatology and Allergy, University Hospital of Bonn, Bonn, Germany.
  • Katoh N; Christine Kühne - Center for Allergy Research and Education, Davos, Switzerland.
  • Simpson EL; Department of Dermatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • de Bruin-Weller M; Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.
  • Thaçi D; Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
  • Torrelo A; Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
  • Sontag A; Department of Dermatology, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
  • Grond S; Eli Lilly and Company, Indianapolis, IN, USA.
  • Issa M; Eli Lilly and Company, Indianapolis, IN, USA.
  • Lu X; Eli Lilly and Company, Indianapolis, IN, USA.
  • Cardillo T; TechData Service Company, King of Prussia, PA, USA.
  • Holzwarth K; Eli Lilly and Company, Indianapolis, IN, USA.
  • Thyssen JP; Eli Lilly and Company, Indianapolis, IN, USA.
J Dermatolog Treat ; 34(1): 2161812, 2023 Dec.
Article en En | MEDLINE | ID: mdl-36546346
BACKGROUND: Baricitinib, a selective Janus kinase (JAK)1/JAK2 inhibitor, is approved for treatment of moderate-to-severe atopic dermatitis (AD) in adults. OBJECTIVES: We report integrated baricitinib safety data in patients with up to 3.9-years exposure. METHODS: Three datasets from the integrated AD clinical trial program were analyzed: placebo-controlled, 2-mg-4-mg extended, and All-bari. Data cutoffs were up to 21-December-2021 for long-term extension studies. Proportions of patients with events and incidence rates (IR)/100 patient years (PY) at risk were calculated. RESULTS: 2636 patients received baricitinib for 4628.4 PY. Discontinuation due to adverse events was low (IR = 3.4). IRs in All-bari were: serious adverse events, 5.2; infection, 67.2 (any infection), 6.7 (herpes simplex), 2.8 (herpes zoster), and 0.3 (opportunistic infections). Adverse events of special interest in All-bari included seven patients with positively adjudicated major adverse cardiovascular events (MACE) (IR = 0.15), three pulmonary emboli (PE) (IR = 0.06), 14 malignancies excluding nonmelanoma skin cancer (IR = 0.3), one gastrointestinal perforation (IR = 0.02), and four deaths (IR = 0.1). No deep vein thromboses (DVT) or tuberculosis were reported. CONCLUSION: In this analysis, baricitinib maintained a similar safety profile to earlier analyses with no new safety signals. Rates of MACE, DVT/PE, malignancies, and serious infections were within ranges of background rates in patients with AD. CLINICALTRIALS.GOV: NCT02576938 (JAHG), NCT03334396 (JAHL; BREEZE-AD1), NCT03334422 (JAHM; BREEZE-AD2), NCT03334435 (JAHN; BREEZE-AD3), NCT03428100 (JAIN; BREEZE-AD4), NCT03435081 (JAIW; BREEZE-AD5), NCT03559270 (JAIX; BREEZE-AD6), NCT03733301 (JAIY; BREEZE-AD7).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azetidinas / Dermatitis Atópica / Inhibidores de las Cinasas Janus / Neoplasias Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: J Dermatolog Treat Asunto de la revista: DERMATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azetidinas / Dermatitis Atópica / Inhibidores de las Cinasas Janus / Neoplasias Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: J Dermatolog Treat Asunto de la revista: DERMATOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido