Abstract
Objective
Although recent clinical trials showed that ultrasound (US) remission is not required to achieve good outcomes at the group level, it currently remains unclear whether the prognosis of individual patients in clinical remission, but not US remission, i.e. those with subclinical sonographic synovitis (SSS), is favorable. However, it is no longer acceptable to perform US on all patients in order to identify those with SSS. Therefore, the present study was initiated to elucidate the conditions under which SSS is frequently detected.
Methods
In total, 563 consecutive RA patients were recruited. Bilateral 2-5 MCP, wrist, ankle, and 2–5 MTP joints were scanned by US, and Gray scale and Power Doppler (PD) images were scored semi-quantitatively. Clinical data were obtained by physicians who were blind to US results. Changes in the modified Total Sharp Score (mTSS) of tocilizumab (TCZ) users were calculated.
Results
A total of 402 patients were included. SSS was more frequently detected in patients with more severe joint deformity, even if they were in remission. In contrast, a high Patient Global Assessment of Disease (PtGA) did not reflect SSS. Furthermore, the relationship between PtGA and PD scores was weak. Although the frequency of SSS was high in TCZ user, the presence of SSS in TCZ users not always results in the progression of mTSS.
Conclusions
While remission is overestimated in patients with severe joint deformity, underestimations may occur in those who do not fulfill remission criteria because of a high PtGA.
Acknowledgments
The authors thank Mr. Wataru Yamamoto at Kurashiki Sweet Hospital for his excellent support to establish and maintain the KURAMA database.
Conflict of interest
The KURAMA cohort study is supported by a grant from Daiichi Sankyo Co., Ltd. This study was conducted as an investigator initiated study. These companies had no role in the design of the study, the collection or analysis of data, the writing of the manuscript, or decision to submit the manuscript for publication.
M.H. and M.T. belong to a department that is financially supported by Nagahama City, Shiga, Japan and four pharmaceutical companies (Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co. Ltd, UCB Japan Co. Ltd, and AYUMI Pharmaceutical Co.).
MH receives research grant and/or speaker fee from Brystol Meyers, Eisai, Eli Lilly, and Tanabe Mitsubishi.
HI has received a research grant and/or speaker fee from Bristol-Myers, Kyocera, and Asahi-Kasei.
TF has received speaking fees and/or honoraria from Abbvie, Astellas, Asahi-kasei, Chugai, Eli Lilly, Eisai, Janssen, Kissei, Mitsubishi-Tanabe, Ono, Pfizer, Sanofi, Taisho Toyama, Takeda, and UCB, and has received research grants from AbbVie, Ayumi, Asahi-kasei, Astellas, Chugai, Daiichi-Sankyo, Eli Lilly, Eisai, Kissei, Mitsubishi-Tanabe, Pfizer, Nippon-Kayaku, Ono, Takeda, and UCB.