| Title |
A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate
|
|---|---|
| Published in |
Rheumatology International, March 2014
|
| DOI | 10.1007/s00296-014-2989-z |
| Pubmed ID | |
| Authors |
Wei Fan, Dong-bao Zhao, Shao-Xian Hu, Hu-ji Xu, Xiao Zhang, Miu-jia Zhang, Zhi-wei Chen, Feng-xiao Zhang, Ping Zhu, Xin-fu Li, Li-qi Bi, Bin Zhou, Chun-de Bao |
| Abstract |
To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized, double-blind, placebo-controlled multicenter study, a total of 440 Chinese patients with active RA with an inadequate response to MTX were randomly assigned to receive Leining (10 mg/kg) or placebo. Clinical response was assessed using the American College of Rheumatology 20 % improvement criteria ACR20, ACR50, and ACR70, with ACR20 as the primary major endpoints. Disease activity scores in 28 joints with erythrocyte sedimentation rate assessment (DAS28-ESR) were used to evaluate disease activity. After 24 weeks of treatment, significantly more patients in Leining group achieved ACR20 response than those in placebo group (70.61 vs. 46.36 %; p < 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %; p < 0.001 and 16.67 vs. 7.27 %; p < 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %, p < 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %; p < 0.05 and 15.45 vs. 2.73 %; p < 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Germany | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 34 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 34 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 24% |
| Student > Ph. D. Student | 6 | 18% |
| Student > Bachelor | 4 | 12% |
| Other | 2 | 6% |
| Student > Doctoral Student | 1 | 3% |
| Other | 4 | 12% |
| Unknown | 9 | 26% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 38% |
| Nursing and Health Professions | 3 | 9% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 6% |
| Biochemistry, Genetics and Molecular Biology | 2 | 6% |
| Computer Science | 1 | 3% |
| Other | 2 | 6% |
| Unknown | 11 | 32% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 25 October 2014.
All research outputs
#20,242,136
of 22,769,322 outputs
Outputs from Rheumatology International
#1,968
of 2,177 outputs
Outputs of similar age
#192,128
of 224,578 outputs
Outputs of similar age from Rheumatology International
#34
of 38 outputs
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