RESEARCH - T-614 compared with MTX in the treatment of active RA

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Arthritis Rheum. 2009 Jun 29;61(7):979-987.

Multicenter, randomized, double-blind, controlled trial of treatment

of active rheumatoid arthritis with T-614 compared with methotrexate.

Lu LJ, Bao CD, Dai M, Teng JL, Fan W, Du F, Yang NP, Zhao YH, Chen ZW,

Xu JH, He PG, Wu HX, Tao Y, Zhang MJ, Han XH, Li XF, Gu JR, Li JH, Yu

H.

Ren Ji Hospital, Shanghai Jiaotong University School of Medicine,

Shanghai, China.

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.

CONCLUSION: 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.

PMID: 19565542

http://www.ncbi.nlm.nih.gov/pubmed/19565542

Not an MD

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Cool, I have a FDA list they email me with when approved

thanks

Kathy