RESEARCH - T-614 may be a new option for RA

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T-614 May Be " a New Option " for Rheumatoid Arthritis Patients

NEW YORK (Reuters Health) Jul 17 - T-614, a methanesulfonanilide being

tested in Japan and China for its activity against rheumatoid

arthritis, was as effective as methotrexate in a 24-week phase III

trial.

As reported in the July 15th issue of Arthritis & Rheumatism by Dr.

Liang-Jing Lu at Shanghai Jiaotong University School of Medicine in

Shanghai and colleagues, 489 patients with active rheumatoid arthritis

were randomized to one of three protocols:

--T-614, starting at 25 mg per day for the first 4 weeks and then

increased to 50 mg per day for the remaining 20 weeks;

--T-614 given at 50 mg per day for the entire 24 weeks; or

--Methotrexate, 10 mg per week for 4 weeks and then 15 mg per week for

the next 20 weeks.

At week 24, there was no statistically significant difference in the

American College of Rheumatology 20% (ACR20) improvement criteria

response rate between patients who took methotrexate (62.0%) and those

given the study drug at 50 mg per day for the entire period (63.8%).

Furthermore, the authors note, " ACR20, ACR50, and ACR70 response rates

at all follow-up time points in the T-614 50 mg per day group were

similar to those in the methotrexate group. "

The 24-week response rate among patients who received 25 mg per day of

T-614 for the first month was inferior to that in both other groups,

at 50.9%.

In all groups, patients had significant decreases in rheumatoid

factor, immunoglobulin (Ig) A, IgG, and IgM.

Side effect profiles of the two agents " suggest that T-614 may be

different from methotrexate in several ways, " the researchers said.

" The most notable difference " was a lower rate of liver enzyme

abnormalities with T-614, although this was still the most common side

effect in both T-614 groups, according to the investigators.

Overall, they report, adverse effects were " generally fewer and

milder " with T-614. An exception was mild skin reactions, which were

more common with T-614.

" Results indicate that T-614 therapy 50 mg per day is effective and

well tolerated, and represents a new option for...patients with active

rheumatoid arthritis, " the authors conclude.

In an upcoming study designed to assess the effect of longer-term

treatment, Chinese patients with early rheumatoid arthritis are going

to be receiving T-614 for 2 years, with progression of articular

destruction monitored by X-rays, the researchers added.

Arthritis Rheum 2009;61:979-987.

http://www.medscape.com/viewarticle/706150

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