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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
(5
): 831-839
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
A randomised phase II study evaluating the efficacy and safety of subcutaneously
administered ustekinumab and guselkumab in patients with active rheumatoid
arthritis despite treatment with methotrexate
#MMPMID28087506
Smolen JS
; Agarwal SK
; Ilivanova E
; Xu XL
; Miao Y
; Zhuang Y
; Nnane I
; Radziszewski W
; Greenspan A
; Beutler A
; Baker D
Ann Rheum Dis
2017[May]; 76
(5
): 831-839
PMID28087506
show ga
OBJECTIVE: Interleukin (IL)-12 and IL-23 have been implicated in the pathogenesis
of rheumatoid arthritis (RA). The safety and efficacy of ustekinumab, a human
monoclonal anti-IL-12/23 p40 antibody, and guselkumab, a human monoclonal
anti-IL-23 antibody, were evaluated in adults with active RA despite methotrexate
(MTX) therapy. METHODS: Patients were randomly assigned (1:1:1:1:1) to receive
placebo at weeks 0, 4 and every 8?weeks (n=55), ustekinumab 90?mg at weeks 0, 4
and every 8?weeks (n=55), ustekinumab 90?mg at weeks 0, 4 and every 12?weeks
(n=55), guselkumab 50?mg at weeks 0, 4 and every 8?weeks (n=55), or guselkumab
200?mg at weeks 0, 4 and every 8?weeks (n=54) through week 28; all patients
continued a stable dose of MTX (10-25?mg/week). The primary end point was the
proportion of patients with at least a 20% improvement in the American College of
Rheumatology criteria (ACR 20) at week 28. Safety was monitored through week 48.
RESULTS: At week 28, there were no statistically significant differences in the
proportions of patients achieving an ACR 20 response between the combined
ustekinumab group (53.6%) or the combined guselkumab group (41.3%) compared with
placebo (40.0%) (p=0.101 and p=0.877, respectively). Through week 48, the
proportions of patients with at least one adverse event (AE) were comparable
among the treatment groups. Infections were the most common type of AE.
CONCLUSIONS: Treatment with ustekinumab or guselkumab did not significantly
reduce the signs and symptoms of RA. No new safety findings were observed with
either treatment. TRIAL REGISTRATION NUMBER: NCT01645280.
|Adult
[MESH]
|Aged
[MESH]
|Antibodies, Monoclonal, Humanized
[MESH]
|Antibodies, Monoclonal/administration &
dosage/immunology/pharmacokinetics/*therapeutic use
[MESH]
|Antirheumatic Agents/administration &
dosage/immunology/pharmacokinetics/*therapeutic use
[MESH]