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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 Mod+Rheumatol
2014 ; 24
(5
): 734-43
Nephropedia Template TP
gab.com Text
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English Wikipedia
Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid
arthritis patients with an inadequate response to methotrexate: 52-week results
from an open-label extension of the J-RAPID study
#MMPMID24593170
Tanaka Y
; Yamamoto K
; Takeuchi T
; Yamanaka H
; Ishiguro N
; Eguchi K
; Watanabe A
; Origasa H
; Shoji T
; Miyasaka N
; Koike T
Mod Rheumatol
2014[Sep]; 24
(5
): 734-43
PMID24593170
show ga
OBJECTIVES: To evaluate the long-term efficacy and safety of certolizumab pegol
(CZP) plus methotrexate treatment and to assess the efficacy of two CZP
maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients with
an inadequate response to methotrexate. METHODS: J-RAPID double-blind patients
were entered into an open-label extension (OLE) study. Patients withdrawn due to
lack of efficacy at 16 weeks and double-blind completers without a week-24
American College of Rheumatology (ACR) 20 response received CZP 200 mg every
other week (Q2W) plus methotrexate. Double-blind completers with week-24 ACR20
responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every
4 weeks plus methotrexate. RESULTS: The ACR20/ACR50/ACR70 response rates of
double-blind completers (n = 204) were 89.7%/67.2%/36.3% at OLE entry and
95.6%/84.8%/58.3% at 52 weeks, respectively. Other clinical, functional and
radiographic outcomes were sustained with long-term CZP plus methotrexate.
Long-term treatment with CZP was well-tolerated with no new unexpected adverse
events observed. The efficacy and safety of CZP treatment were similar between
the two dosing schedules. CONCLUSIONS: Continued CZP administration with
methotrexate maintained efficacy over 52 weeks and was well-tolerated for
Japanese RA patients. No obvious differences in clinical efficacy and safety were
observed between the two dosing schedules, giving flexibility in maintenance
administration schedules.
|Adult
[MESH]
|Aged
[MESH]
|Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
[MESH]
|Antirheumatic Agents/adverse effects/*therapeutic use
[MESH]