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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ann+Rheum+Dis
2017 ; 76
(7
): 1253-1262
Nephropedia Template TP
gab.com Text
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English Wikipedia
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
#MMPMID28143815
Cohen 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
Ann Rheum Dis
2017[Jul]; 76
(7
): 1253-1262
PMID28143815
show ga
OBJECTIVES: 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. TRIAL REGISTRATION NUMBERS: NCT01262118, NCT01484561, NCT00147498,
NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT01164579, NCT00976599,
NCT01059864, NCT01359150, NCT00960440, NCT00847613, NCT00814307, NCT00856544,
NCT00853385, NCT01039688, NCT00413699, NCT00661661; Results.