Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs.
Influenza
JAK inhibitor
Psoriatic arthritis
Rheumatoid arthritis
Safety
Tofacitinib
Ulcerative colitis
Viral infection
Journal
Rheumatology and therapy
ISSN: 2198-6576
Titre abrégé: Rheumatol Ther
Pays: England
ID NLM: 101674543
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
22
08
2022
accepted:
03
11
2022
pubmed:
17
12
2022
medline:
17
12
2022
entrez:
16
12
2022
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 36526796
doi: 10.1007/s40744-022-00507-z
pii: 10.1007/s40744-022-00507-z
pmc: PMC9758022
doi:
Banques de données
ClinicalTrials.gov
['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']
Types de publication
Journal Article
Langues
eng
Pagination
357-373Informations de copyright
© 2022. The Author(s).
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