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Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial.
Chin Med J (Engl). 2008 Apr 05; 121(7):615-9.CM

Abstract

BACKGROUND

A novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients.

METHODS

In a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo (n = 95) or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology (ACR) response rate using the intent-to-treat population.

RESULTS

The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and c-reactive protein (CRP) were significantly different in the treatment groups after 24 weeks. The incidence of adverse events (AEs) was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups.

CONCLUSION

T-614, a new slow-acting drug, is effective in treatment of rheumatoid arthritis and is well tolerated.

Authors+Show Affiliations

Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200001, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18466681

Citation

Lü, Liang-jing, et al. "Safety and Efficacy of T-614 in the Treatment of Patients With Active Rheumatoid Arthritis: a Double Blind, Randomized, Placebo-controlled and Multicenter Trial." Chinese Medical Journal, vol. 121, no. 7, 2008, pp. 615-9.
Lü LJ, Teng JL, Bao CD, et al. Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial. Chin Med J (Engl). 2008;121(7):615-9.
Lü, L. J., Teng, J. L., Bao, C. D., Han, X. H., Sun, L. Y., Xu, J. H., Li, X. F., & Wu, H. X. (2008). Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial. Chinese Medical Journal, 121(7), 615-9.
Lü LJ, et al. Safety and Efficacy of T-614 in the Treatment of Patients With Active Rheumatoid Arthritis: a Double Blind, Randomized, Placebo-controlled and Multicenter Trial. Chin Med J (Engl). 2008 Apr 5;121(7):615-9. PubMed PMID: 18466681.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial. AU - Lü,Liang-jing, AU - Teng,Jia-lin, AU - Bao,Chun-de, AU - Han,Xing-hai, AU - Sun,Ling-yun, AU - Xu,Jiang-hua, AU - Li,Xing-fu, AU - Wu,Hua-xiang, PY - 2008/5/10/pubmed PY - 2008/7/9/medline PY - 2008/5/10/entrez SP - 615 EP - 9 JF - Chinese medical journal JO - Chin Med J (Engl) VL - 121 IS - 7 N2 - BACKGROUND: A novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients. METHODS: In a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo (n = 95) or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology (ACR) response rate using the intent-to-treat population. RESULTS: The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and c-reactive protein (CRP) were significantly different in the treatment groups after 24 weeks. The incidence of adverse events (AEs) was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups. CONCLUSION: T-614, a new slow-acting drug, is effective in treatment of rheumatoid arthritis and is well tolerated. SN - 0366-6999 UR - https://www.unboundmedicine.com/medline/citation/18466681/Safety_and_efficacy_of_T_614_in_the_treatment_of_patients_with_active_rheumatoid_arthritis:_a_double_blind_randomized_placebo_controlled_and_multicenter_trial_ L2 - https://Insights.ovid.com/pubmed?pmid=18466681 DB - PRIME DP - Unbound Medicine ER -