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Adverse
events after tofacitinib exposure up to 8.5 years were found to be stable. No
new information on tofacitinib risk profile compared to previous studies was
found.
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 recognized compared with last
tofacitinib reports.
Annals of Rheumatic Diseases
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.
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