Scientists Evaluated the Long-Term Safety of Tofacitinib for the Treatment of Rheumatoid Arthritis

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Scientists Evaluated the Long-Term Safety of Tofacitinib for the Treatment of Rheumatoid Arthritis

A recent study was undertaken to evaluate the long-term safety of tofacitinib to treat rheumatoid arthritis (RA). Researchers assessed effects and AEs of tofacitinib up to 8.5 of RA treatment. The efficacy and integrated safety of tofacitinib were evaluated from two studies in phase I, nine in phase II, six phase III and two long-term extension studies in adult patients with active RA.

Data for this study was extracted from all tofacitinib-treated RA patients in phases I–III and LTE studies (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.

During the study from total 19 406 patient-years' exposure, 6194 patients received tofacitinib. The overall median exposure was 3.4 patient-years. The IR noted (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 (all) found for 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). Incidence rates for opportunistic infections (excluding tuberculosis) was 0.3 (0.2 to 0.4). 0.2 (0.1 to 0.3) was for tuberculosis. Incidence rates toward 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). Incidence rates for GIT perforations was 0.1 (0.1 to 0.2). IR analysis done for serious infections, herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in IR with longer-duration tofacitinib exposure.

The conclusion came out that the analysis is done for tofacitinib exposure up to 8.5 years, provided for the estimation of safety events with improved precision versus previous tofacitinib reports. AEs were observed to be stable over time. Such as no new safety signals were recognised compared with last tofacitinib reports.


Annals of Rheumatic Diseases

Link to the source:

Original title of article:

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


Stanley B Cohen, YoShiya Tanaka et al.

Therapeutic, Tofacitinib, Rheumatoid arthritis, Janus kinase inhibitor, Phase I, Phase II, Phase III, Safety, Oral
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