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dc.contributor.authorBurmester, Gerd R
dc.contributor.authorNash, Peter
dc.contributor.authorSands, Bruce E
dc.contributor.authorPapp, Kim
dc.contributor.authorStockert, Lori
dc.contributor.authorJones, Thomas V
dc.contributor.authorTan, Huaming
dc.contributor.authorMadsen, Ann
dc.contributor.authorValdez, Hernan
dc.contributor.authorCohen, Stanley B
dc.date.accessioned2021-06-07T23:49:19Z
dc.date.available2021-06-07T23:49:19Z
dc.date.issued2021
dc.identifier.issn2056-5933
dc.identifier.doi10.1136/rmdopen-2021-001595
dc.identifier.urihttp://hdl.handle.net/10072/404962
dc.description.abstractOBJECTIVES: To analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases. METHODS: The analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest. RESULTS: 13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the 'infections and infestations' System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts. CONCLUSIONS: The tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherBMJ
dc.relation.ispartofpagefrome001595
dc.relation.ispartofissue2
dc.relation.ispartofjournalRMD Open
dc.relation.ispartofvolume7
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3202
dc.subject.keywordsarthritis
dc.subject.keywordsautoimmune diseases
dc.subject.keywordspsoriatic
dc.subject.keywordsrheumatoid
dc.subject.keywordstherapeutics
dc.titleAdverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationBurmester, GR; Nash, P; Sands, BE; Papp, K; Stockert, L; Jones, TV; Tan, H; Madsen, A; Valdez, H; Cohen, SB, Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure., RMD Open, 2021, 7 (2), pp. e001595
dcterms.dateAccepted2021-05-04
dcterms.licensehttps://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-06-07T23:22:22Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© Author(s) (or their employer(s)) 2021. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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