Session Information
Date: Tuesday, November 15, 2016
Session Title: Sjögren's Syndrome - Poster II: Clinical Science
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Iguratimod (IGU), a methanesulfonanilide, has been used as a novel disease-modifying antirheumatic drug for treatment of rheumatoid arthritis in Japan and China. IGU displayed significantly inhibition of immunoglobulin production and suppression of IL-1, IL-6 and TNF. Previous studies have indicated an overt activation of B cells leading to the abnormal secretory function and accompanied by autoantibody production and hypergammaglobulinemia in Primary Sjögren’s Syndrome (pSS). The aim of this study was to investigate the efficacy of IGU in combination with conventional treatment in pSS and the effects of IGU on B cell activity.
Methods: A total of 50 female patients diagnosed with pSS meeting the international classification criteria (2002) were enrolled in this study, with a mean age of 29.3 ± 9.7 years. Active pSS patients were randomized (1:1) to conventional treatment (prednisone ≤ 10 mg daily, hydroxychloroquine 400mg daily and new hydrochloride bromide ethyl daily), or IGU treatment (conventional treatment plus IGU 50 mg daily). pSS disease activity was assessed using EULAR Sjögren’s syndrome disease activity index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI). Expression of CD135, IgD, CD38, CD20 and B cell activating factor-receptor (BAFF-R) on peripheral blood B cells were analyzed by flow cytometry in 20 pSS patients before and after treatment at 12 weeks.
Results: As shown in Table 1, at week 12, ESSDAI and ESSPRI were significantly improved but with a much greater gratitude in IGU treated group as compared with those in conventional treatment group (P<0.05). There were no obvious adverse events reported in either group. At baseline, pSS patients showed a significant increased expression of BAFF-R, CD38, CD135 and IgD on B cells compared with that in healthy controls. After 12 weeks of treatment, expression of BAFF-R, CD38, and IgD in IGU treatment group decreased significantly than that in conventional treatment group (Table 2) (P<0.05).
Conclusion: In subjects with pSS, IGU treatment resulted in clinically meaningful improvements in disease activity compared with conventional therapy. IGU affected B cell frequency and functions in pSS via inhibition of BAFF-R expression on B cells and inhibition of B cell antibody production.
Table 1. Disease activity before and after treatment in pSS patients
|
|
IGU (n=25) |
|
Conventional (n=25) |
P1* |
||||
|
|
Before |
After |
P |
Before |
After |
P |
|
|
|
ESSPRI |
6.3 |
2.9 |
<0.05 |
|
7.1 |
5.1 |
<0.05 |
<0.05 |
|
ESSDAI |
13.7 |
6.4 |
<0.05 |
12.2 |
8.0 |
<0.05 |
<0.05 |
|
* P1 value represents comparison of changes after treatment between IGU and
Conventional groups.
Table 2. Expression of B cell markers before and after treatment in pSS patients
|
|
IGU (n=10) |
|
Conventional (n=10) |
P1* |
||||
|
|
Before |
After |
P |
Before |
After |
P |
|
|
|
BAFF-R (%) |
92.5 |
69.4 |
<0.05 |
|
94.1 |
79.8 |
<0.05 |
<0.05 |
|
CD38,IgD (%) |
74.9 |
43.4 |
<0.05 |
80.6 |
60.2 |
<0.05 |
<0.05 |
|
* P1 value represents comparison of changes after treatment between IGU and
Conventional groups.
To cite this abstract in AMA style:
Zhang L, Jiang W, Chu CQ, Liu Y. Therapeutic Efficacy of Iguratimod in Patients with Primary Sjogren’s Syndrome [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/therapeutic-efficacy-of-iguratimod-in-patients-with-primary-sjogrens-syndrome/. Accessed September 22, 2019.« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/therapeutic-efficacy-of-iguratimod-in-patients-with-primary-sjogrens-syndrome/