PMID- 36526796 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230314 IS - 2198-6576 (Print) IS - 2198-6584 (Electronic) IS - 2198-6576 (Linking) VI - 10 IP - 2 DP - 2023 Apr TI - Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. PG - 357-373 LID - 10.1007/s40744-022-00507-z [doi] AB - 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. TRIAL REGISTRATION NUMBERS: 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. CI - (c) 2022. The Author(s). FAU - Winthrop, Kevin L AU - Winthrop KL AUID- ORCID: 0000-0002-3892-6947 AD - School of Medicine, Oregon Health and Science University, 3375 SW Terwilliger Blvd, Portland, OR, 97239, USA. Winthrop@ohsu.edu. FAU - Yndestad, Arne AU - Yndestad A AUID- ORCID: 0000-0003-0855-1379 AD - Pfizer Inc, Oslo, Norway. FAU - Henrohn, Dan AU - Henrohn D AUID- ORCID: 0000-0001-9514-1153 AD - Pfizer AB, Sollentuna, Sweden. AD - Department of Medical Sciences, Uppsala University, Uppsala, Sweden. FAU - Danese, Silvio AU - Danese S AUID- ORCID: 0000-0001-7341-1351 AD - Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy. FAU - Marsal, Sara AU - Marsal S AUID- ORCID: 0000-0001-5515-3854 AD - Rheumatology Department, Vall d'Hebron Hospital, Barcelona, Spain. FAU - Galindo, Maria AU - Galindo M AD - Rheumatology Unit, Hospital Universitario, 12 de Octubre, Madrid, Spain. FAU - Woolcott, John C AU - Woolcott JC AD - Pfizer Inc, Collegeville, PA, USA. FAU - Jo, Hyejin AU - Jo H AD - Pfizer Inc, New York, NY, USA. FAU - Kwok, Kenneth AU - Kwok K AUID- ORCID: 0000-0002-7475-3369 AD - Pfizer Inc, New York, NY, USA. FAU - Shapiro, Andrea B AU - Shapiro AB AD - Pfizer Inc, Peapack, NJ, USA. FAU - Jones, Thomas V AU - Jones TV AD - Pfizer Inc, Collegeville, PA, USA. FAU - Diehl, Annette AU - Diehl A AD - Pfizer Inc, Collegeville, PA, USA. FAU - Su, Chinyu AU - Su C AUID- ORCID: 0000-0001-7703-4901 AD - Pfizer Inc, Collegeville, PA, USA. FAU - Panes, Julian AU - Panes J AUID- ORCID: 0000-0002-4971-6902 AD - IBD Unit, Gastroenterology Department, Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. FAU - Cohen, Stanley B AU - Cohen SB AUID- ORCID: 0000-0002-9226-979X AD - Metroplex Clinical Research Center, Dallas, TX, USA. LA - eng SI - ClinicalTrials.gov/NCT01262118 SI - ClinicalTrials.gov/NCT01484561 SI - ClinicalTrials.gov/NCT00147498 SI - ClinicalTrials.gov/NCT00413660 SI - ClinicalTrials.gov/NCT00550446 SI - ClinicalTrials.gov/NCT00603512 SI - ClinicalTrials.gov/NCT00687193 SI - ClinicalTrials.gov/NCT01164579 SI - ClinicalTrials.gov/NCT00976599 SI - ClinicalTrials.gov/NCT01059864 SI - ClinicalTrials.gov/NCT01359150 SI - ClinicalTrials.gov/NCT02147587 SI - ClinicalTrials.gov/NCT00960440 SI - ClinicalTrials.gov/NCT00847613 SI - ClinicalTrials.gov/NCT00814307 SI - ClinicalTrials.gov/NCT00856544 SI - ClinicalTrials.gov/NCT00853385 SI - ClinicalTrials.gov/NCT01039688 SI - ClinicalTrials.gov/NCT02281552 SI - ClinicalTrials.gov/NCT02187055 SI - ClinicalTrials.gov/NCT02831855 SI - ClinicalTrials.gov/NCT00413699 SI - ClinicalTrials.gov/NCT00661661 SI - ClinicalTrials.gov/NCT00787202 SI - ClinicalTrials.gov/NCT01465763 SI - ClinicalTrials.gov/NCT01458951 SI - ClinicalTrials.gov/NCT01458574 SI - ClinicalTrials.gov/NCT01470612 SI - ClinicalTrials.gov/NCT01877668 SI - ClinicalTrials.gov/NCT01882439 SI - ClinicalTrials.gov/NCT01976364 PT - Journal Article DEP - 20221217 PL - England TA - Rheumatol Ther JT - Rheumatology and therapy JID - 101674543 PMC - PMC9758022 OTO - NOTNLM OT - Influenza OT - JAK inhibitor OT - Psoriatic arthritis OT - Rheumatoid arthritis OT - Safety OT - Tofacitinib OT - Ulcerative colitis OT - Viral infection EDAT- 2022/12/17 06:00 MHDA- 2022/12/17 06:01 PMCR- 2022/12/17 CRDT- 2022/12/16 23:34 PHST- 2022/08/22 00:00 [received] PHST- 2022/11/03 00:00 [accepted] PHST- 2022/12/17 06:00 [pubmed] PHST- 2022/12/17 06:01 [medline] PHST- 2022/12/16 23:34 [entrez] PHST- 2022/12/17 00:00 [pmc-release] AID - 10.1007/s40744-022-00507-z [pii] AID - 507 [pii] AID - 10.1007/s40744-022-00507-z [doi] PST - ppublish SO - Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.