ABSTRACT
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.
Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Benzopyrans/therapeutic use , Methotrexate/therapeutic use , Sulfonamides/therapeutic use , Administration, Oral , Adult , Antirheumatic Agents/administration & dosage , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/blood , Arthritis, Rheumatoid/immunology , Benzopyrans/administration & dosage , Benzopyrans/adverse effects , China , Double-Blind Method , Female , Humans , Immunoglobulin A/blood , Immunoglobulin G/blood , Immunoglobulin M/blood , Male , Methotrexate/administration & dosage , Methotrexate/adverse effects , Middle Aged , Sulfonamides/administration & dosage , Sulfonamides/adverse effects , Treatment OutcomeABSTRACT
AIM: To construct eukaryotic expression vector of human T-cell immunoglobulin mucin 3(TIM-3) and transfect mammalian cells to establish stable cell line. METHODS: The whole coding region of TIM-3 was amplified by PCR and inserted into eukaryotic expression vector pIRES2EGFP. The recombinant plasmid was transfected into mammalian cells by Lipofectamine. The expression product was analyzed by flow cytometry and Western blot. The stable transfectant was screened and established by flow cytometry and selective medium. RESULTS: COS-7 and CHO cells were transfected with recombinant plasmid by Lipofectamine. The expression speciality was identified by Flow cytometry and Western blot. The stable transfectant of CHO cell line was established. CONCLUSION: The whole coding region of TIM-3 was successfully subcloned into eukaryotic expression vector and expressed on the surface of mammalian cells. The stable transfectant of CHO cell line was established.
