Sistema de Salut de Catalunya
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
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.
Article
Published version
English
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
Springer
Rheumatology and Therapy;10
https://doi.org/10.1007/s40744-022-00507-z
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
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