Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs

Autor: Kevin L. Winthrop, Arne Yndestad, Dan Henrohn, Silvio Danese, Sara Marsal, Maria Galindo, John C. Woolcott, Hyejin Jo, Kenneth Kwok, Andrea B. Shapiro, Thomas V. Jones, Annette Diehl, Chinyu Su, Julian Panés, Stanley B. Cohen
Přispěvatelé: Institut Català de la Salut, [Winthrop KL] School of Medicine, Oregon Health and Science University, Portland, USA. [Yndestad A] Pfizer Inc, Oslo, Norway. [Henrohn D] Pfizer AB, Sollentuna, Sweden. Department of Medical Sciences, Uppsala University, Uppsala, Sweden. [Danese S] Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy. [Marsal S] Servei de Reumatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Galindo M] Rheumatology Unit, Hospital Universitario, 12 de Octubre, Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Grip - Complicacions
virosis::infecciones por virus ARN::infecciones por Orthomyxoviridae::gripe humana [ENFERMEDADES]
acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas [COMPUESTOS QUÍMICOS Y DROGAS]
Public Health
Global Health
Social Medicine and Epidemiology
Artritis reumatoide
Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors [CHEMICALS AND DRUGS]
Influenza
enfermedades musculoesqueléticas::artropatías::artritis::artritis reumatoide [ENFERMEDADES]
Proteïnes quinases - Inhibidors
Otros calificadores::Otros calificadores::/complicaciones [Otros calificadores]
Folkhälsovetenskap
global hälsa
socialmedicin och epidemiologi
Rheumatology
Ulcerative colitis
JAK inhibitor
Tofacitinib
Viral infection
Psoriatic arthritis
Immunology and Allergy
Rheumatoid arthritis
Safety
Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza
Human [DISEASES]
Musculoskeletal Diseases::Joint Diseases::Arthritis::Arthritis
Rheumatoid [DISEASES]
Other subheadings::Other subheadings::/complications [Other subheadings]
Zdroj: Scientia
Popis: This post hoc analysis evaluated influenza adverse events (AEs) across rheumatoid arthritis (RA), ulcerative colitis (UC), and psoriatic arthritis (PsA) tofacitinib clinical programs.Available data from phase 1, randomized phase 2/3/3b/4 clinical trials (completed by 2018), and long-term extension (LTE) studies (up to May 2019) in patients with RA, UC, and PsA were included [randomized or Overall (phase 1-3b/4 and LTE studies) tofacitinib cohorts]. Incidence rates (IRs; events per 100 patient-years) of combined influenza AEs (seasons 2004/2005 to 2018/2019) were analyzed, including by tofacitinib dose [5 or 10 mg twice daily (BID)] and age ( 65 versus ≥ 65 years). Logistic regression models evaluated risk factors for influenza AEs in the RA Overall tofacitinib cohort.In randomized cohorts, combined influenza AE IRs were generally similar across tofacitinib, adalimumab, methotrexate, and placebo groups, across indications. Among Overall tofacitinib cohorts, combined influenza AE IRs with tofacitinib 5/10 mg BID, respectively, were higher in the UC (3.66/5.09) versus RA (2.38/2.19) and PsA (1.74/1.29) cohorts. IRs were generally similar across tofacitinib dose and age groups. Most influenza AEs were nonserious and did not require changes to tofacitinib treatment. Significant risk factors for influenza AEs in patients with RA were geographic region, baseline oral corticosteroid and methotrexate use, and tofacitinib dose.In the RA, UC, and PsA clinical programs, combined influenza AE IRs were highest in UC, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups. Influenza AEs were predominantly nonserious and not associated with changes to tofacitinib treatment.NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT02147587, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02281552, NCT02187055, NCT02831855, NCT00413699, NCT00661661, NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612, NCT01877668, NCT01882439, NCT01976364.
Databáze: OpenAIRE
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