In:
Chinese Medical Journal, Ovid Technologies (Wolters Kluwer Health), Vol. 134, No. 12 ( 2021-05-19), p. 1457-1464
Abstract:
Clinical observational studies revealed that 99 Tc-methylene diphosphonate ( 99 Tc-MDP) could reduce joint pain and swollenness in rheumatoid arthritis (RA) patients. This multicenter, randomized, double-blind, double-dummy study aimed to evaluate the effects of 99 Tc-MDP plus methotrexate (MTX) vs . MTX alone or 99 Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA. Methods: Eligible patients with moderate to severely active RA were randomized to receive 99 Tc-MDP plus MTX ( n = 59) vs. MTX ( n = 59) alone or 99 Tc-MDP ( n = 59) alone for 48 weeks from six study sites across four provinces in China. The primary outcomes were the American College of Rheumatology 20% improvement (ACR20) response rates at week 24 and changes in modified total Sharp score at week 48. Results: At week 24, the proportion of participants achieving ACR20 was significantly higher in the MTX + 99 Tc-MDP combination group (69.5%) than that in the MTX group (50.8%) or 99 Tc-MDP group (47.5%) ( P = 0.03 for MTX + 99 Tc-MDP vs. MTX, and MTX + 99 Tc-MDP vs. 99 Tc-MDP, respectively). The participants in the MTX + 99 Tc-MDP group and the 99 Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48 weeks (MTX + 99 Tc-MDP vs. MTX: P = 0.03, 99 Tc-MDP vs. MTX: P = 0.03, respectively). There was no significant difference in terms of adverse events (AEs) among the groups. No serious AEs were observed. Conclusions: This study demonstrated that the combination of 99 Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and 99 Tc-MDP monotherapies, without increasing the rate of AEs. Additional clinical studies of 99 Tc-MDP therapy in patients with RA are warranted. Trial Registration: Chictr.org, ChiCTR-IPR-14005684; http://www.chictr.org.cn/showproj.aspx?proj=10088.
Type of Medium:
Online Resource
ISSN:
0366-6999
,
2542-5641
DOI:
10.1097/CM9.0000000000001527
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2021
detail.hit.zdb_id:
2108782-9
SSG:
6,25
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