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dc.contributor.authorCohen, Stanley B
dc.contributor.authorTanaka, Yoshiya
dc.contributor.authorMariette, Xavier
dc.contributor.authorCurtis, Jeffrey R
dc.contributor.authorLee, Eun Bong
dc.contributor.authorNash, Peter
dc.contributor.authorWinthrop, Kevin L
dc.contributor.authorCharles-Schoeman, Christina
dc.contributor.authorThirunavukkarasu, Krishan
dc.contributor.authorDeMasi, Ryan
dc.contributor.authorGeier, Jamie
dc.contributor.authorKwok, Kenneth
dc.contributor.authorWang, Lisy
dc.contributor.authorRiese, Richard
dc.contributor.authorWollenhaupt, Jürgen
dc.description.abstractObjectives: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We report an integrated safety summary of tofacitinib from two phase I, nine phase II, six phase III and two long-term extension studies in adult patients with active RA. Methods: Data were pooled for all tofacitinib-treated patients (data cut-off: 31 March 2015). Incidence rates (IRs; patients with event/100 patient-years) and 95% CIs are reported for adverse events (AEs) of interest. Results: 6194 patients received tofacitinib for a total 19 406 patient-years' exposure; median exposure was 3.4 patient-years. IR (95% CI) for serious AEs was 9.4 (9.0 to 9.9); IR for serious infections was 2.7 (2.5 to 3.0). IR for (all) herpes zoster was 3.9 (3.6 to 4.2); IR for disseminated or multidermatomal herpes zoster was 0.3 (0.2 to 0.4). IR for opportunistic infections (excluding tuberculosis) was 0.3 (0.2 to 0.4) and was 0.2 (0.1 to 0.3) for tuberculosis. IR for malignancies (excluding non-melanoma skin cancer (NMSC)) was 0.9 (0.8 to 1.0); NMSC IR was 0.6 (0.5 to 0.7). IR for gastrointestinal perforations was 0.1 (0.1 to 0.2). Analysis of IR for serious infections, herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in IR with longer-duration tofacitinib exposure. Conclusion: This analysis of tofacitinib exposure up to 8.5 years allowed estimation of safety events with improved precision versus previous tofacitinib reports. AEs were generally stable over time; no new safety signals were observed compared with previous tofacitinib reports.en_US
dc.publisherBMJ Publishing Groupen_US
dc.relation.ispartofjournalAnnals of the Rheumatic Diseasesen_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchPublic Health and Health Servicesen_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsANTI-TNF THERAPYen_US
dc.titleLong-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: Integrated analysis of data from the global clinical trialsen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationCohen, SB; Tanaka, Y; Mariette, X; Curtis, JR; Lee, EB; Nash, P; Winthrop, KL; Charles-Schoeman, C; Thirunavukkarasu, K; DeMasi, R; Geier, J; Kwok, K; Wang, L; Riese, R; Wollenhaupt, J, Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: Integrated analysis of data from the global clinical trials, Annals of the Rheumatic Diseases, 2017, 76 (7), pp. 1253-1262en_US
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gro.griffith.authorNash, Peter

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