In:
Arthritis Care & Research, Wiley, Vol. 61, No. 7 ( 2009-07-15), p. 979-987
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
0893-7524
,
1529-0123
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2009
ZDB Id:
2016713-1
ZDB Id:
2754614-7
