2026-04-17T22:50:17Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/99912025-10-24T10:22:39Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Winthrop, Kevin author Yndestad, Arne author Henrohn, Dan author Danese, Silvio author marsal, sara author Galindo, Maria author 2023-07-07T12:07:32Z 2023-07-07T12:07:32Z 2023-04 Gripe; Artritis psoriásica; Colitis ulcerosa Influenza; Psoriatic arthritis; Ulcerative colitis Grip; Artritis psoriàsica; Colitis ulcerosa Introduction This post hoc analysis evaluated influenza adverse events (AEs) across rheumatoid arthritis (RA), ulcerative colitis (UC), and psoriatic arthritis (PsA) tofacitinib clinical programs. Methods 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. Results 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. Conclusions 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. This study was sponsored by Pfizer. Medical writing support was funded by Pfizer. The journal’s Rapid Service Fee for this article was also funded by Pfizer. http://hdl.handle.net/11351/9991 Grip - Complicacions Proteïnes quinases - Inhibidors Artritis reumatoide DISEASES::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Human Other subheadings::Other subheadings::Other subheadings::/complications DISEASES::Musculoskeletal Diseases::Joint Diseases::Arthritis::Arthritis, Rheumatoid CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Orthomyxoviridae::gripe humana Otros calificadores::Otros calificadores::Otros calificadores::/complicaciones ENFERMEDADES::enfermedades musculoesqueléticas::artropatías::artritis::artritis reumatoide COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs