Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate.
OBJECTIVE
To assess the efficacy and safety of T-614 versus methotrexate (MTX) in patients with active rheumatoid arthritis (RA).


METHODS
In this multicenter, double-blind trial, 489 patients randomly received either T-614 25 mg/day for the first 4 weeks and 50 mg/day for the subsequent 20 weeks (group 1, n = 163), T-614 50 mg/day for 24 weeks (group 2, n = 163), or MTX 10 mg/week for the first 4 weeks and 15 mg/week for the subsequent 20 weeks (n = 163). Clinical and laboratory parameters were analyzed at baseline and at 4, 10, 17, and 24 weeks.


RESULTS
After 24 weeks of treatment, the American College of Rheumatology 20% improvement criteria response rate for patients in T-614 group 2 (63.8%) was not statistically significantly different from that for patients receiving MTX treatment (62.0%), and was superior to that for patients in T-614 group 1 (50.9%). The result of the noninferiority analysis indicated that the efficacy of T-614 (50 mg/day) was not lower than that of MTX by <10%. Rheumatoid factor and IgA, IgG, and IgM demonstrated a statistically significant decrease in all groups. Frequently reported adverse events included hematologic disorder, skin reactions, gastrointestinal symptoms, and transient liver enzyme elevations in the T-614 therapy groups. Side effects in the T-614 groups were generally fewer and milder than in the MTX group, except for skin reactions. There were no prominent cardiovascular adverse events and gastrointestinal ulcers found in the T-614 groups.


CONCLUSIONS
Results indicate that T-614 therapy 50 mg/day is effective and well tolerated, and represents a new option for the treatment of patients with active RA.
Lu
Liang-Jing
LJ
Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Bao
Chun-de
CD
Dai
Min
M
Teng
Jia-Lin
JL
Fan
Wei
W
Du
Fang
F
Yang
Nan-Ping
NP
Zhao
Yin-Huan
YH
Chen
Zhi-Wei
ZW
Xu
Jian-Hua
JH
He
Pei-Gen
PG
Wu
Hua-Xiang
HX
Tao
Yi
Y
Zhang
Miao-Jia
MJ
Han
Xing-Hai
XH
Li
Xing-Fu
XF
Gu
Jie-Ruo
JR
Li
Jian-Hua
JH
Yu
Hao
H
D000284:Administration, Oral; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D001578:Benzopyrans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D001578:Benzopyrans; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D013449:Sulfonamides; C077313:T 614; D008727:Methotrexate