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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, 2017-07, Vol.76 (7), p.1253-1262 [Peer Reviewed Journal]

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing ;Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. ;Copyright: 2017 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing ;Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 2017 ;ISSN: 0003-4967 ;EISSN: 1468-2060 ;DOI: 10.1136/annrheumdis-2016-210457 ;PMID: 28143815

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Title:
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
Author: Cohen, Stanley B ; Tanaka, Yoshiya ; Mariette, Xavier ; Curtis, Jeffrey R ; Lee, Eun Bong ; Nash, Peter ; Winthrop, Kevin L ; Charles-Schoeman, Christina ; Thirunavukkarasu, Krishan ; DeMasi, Ryan ; Geier, Jamie ; Kwok, Kenneth ; Wang, Lisy ; Riese, Richard ; Wollenhaupt, Jürgen
Subjects: Adolescent ; Adult ; Aged ; Aged, 80 and over ; Algorithms ; Arthritis, Rheumatoid - drug therapy ; Cancer therapies ; Chronic obstructive pulmonary disease ; Clinical and Epidemiological Research ; Clinical trials ; Clinical Trials as Topic ; Data collection ; Data processing ; Female ; Health risk assessment ; Herpes zoster ; Herpes Zoster - epidemiology ; Herpes Zoster - etiology ; Herpes Zoster - immunology ; Humans ; Immunocompromised Host ; Incidence ; Infections ; Infections - epidemiology ; Infections - etiology ; Infections - immunology ; Inflammatory diseases ; Janus kinase ; Male ; Melanoma ; Middle Aged ; Neoplasms - epidemiology ; Neoplasms - etiology ; Neoplasms - immunology ; Opportunistic Infections - epidemiology ; Opportunistic Infections - etiology ; Opportunistic Infections - immunology ; Piperidines - adverse effects ; Protein Kinase Inhibitors - adverse effects ; Pyrimidines - adverse effects ; Pyrroles - adverse effects ; Rheumatoid arthritis ; Skin cancer ; Studies ; Surveillance ; Time Factors ; Tuberculosis ; Tuberculosis - epidemiology ; Tuberculosis - etiology ; Tuberculosis - immunology ; Young Adult
Is Part Of: Annals of the rheumatic diseases, 2017-07, Vol.76 (7), p.1253-1262
Description: ObjectivesTofacitinib 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.MethodsData 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.Results6194 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.ConclusionThis 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.Trial registration numbers NCT01262118, NCT01484561, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT00413699, NCT00661661; Results.
Publisher: England: BMJ Publishing Group LTD
Language: English
Identifier: ISSN: 0003-4967
EISSN: 1468-2060
DOI: 10.1136/annrheumdis-2016-210457
PMID: 28143815
Source: BMJ Open Access Journals
MEDLINE
ProQuest Central

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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

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