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Abstract Number: 2017

Prospective Study of Bio-Free Remission Maintenance Using Ultrasonography in Rheumatoid Arthritis Patients: 52-Week Result

Koichi Amano1, Kazutoshi Aoki2, Yoshiaki Kuga3, Koji Nishimura4, Hayato Nagasawa5, Takuma Tsuzuki Wada6, Kenji Takagi7, Junji Hayashi8, Motohide Kaneko9, Ryota Sakai10, Akiko Shibata11, Kentaro Chino11, Shuntaro Saito11, Ayumi Okuyama12, Tsuneo Kondo12, Hirofumi Takei12 and Toshihide Mimura13, 1Department of Rheumatology and Clinical Immunology,, Saitama Medical Center, Saitama Medical University, Saitama, Japan, 2Aoki Clinic, Saitama, Japan, 3Wakaba Hospital, Sakado, Japan, 4internal medicine, Saitama Medical Center, Japan Community Health care Organization, Saitama, Japan, 5Nagasawa Clinic, Kawagoe, Japan, 6Department of Rheumatology and Applied Immunology, Faculty of Medicine,, Saitama Medical University, Saitama, Japan, 7Rheumatology and Clinical Immunology, Higashi-Omiya General Hospital, Saitama, Japan, 8Orthopedic Surgery, Niizashiki Chuo General Hospital, Niiza, Japan, 9Kaneko Clinic, Kawaguchi, Japan, 10Microbiology and Immunology, Keio University School of Medicine, Tokyo, Japan, 11Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan, 12Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan, 13Department of Rheumatology and Applied Immunology, Faculty of Medicine, Saitama Medical University, Saitama, Japan

Meeting: ACR/ARHP Annual Meeting 2017

Date of first publication: September 18, 2017

Keywords: , ,

Session Information

Date: Tuesday, November 7, 2017

Title: Imaging of Rheumatic Diseases Poster II

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Recently, a significant number of rheumatoid arthritis (RA) patients can reach low disease activity (LDA) by using biologics such as adalimumab. However biologics therapy can sometimes cause serious side-effects and is expensive. Therefore, it could be expedient to discontinue biologics after achieving sustained remission or LDA. Ultrasonography seems to be a good predictor of relapse in this respect in several studies. The PRIMULA (Prospective study of Remission Induction & Maintenance using ULtrasonograpy in rheumatoid Arthritis) study, is a multicenter prospective study to investigate if ultrasonography (US)-based evaluation could provide an additive value to composite measure-based evaluation for clinical relapse and radiological progression in RA patients who discontinued adalimumab after obtaining sustained LDA.

Methods: Thirty-one RA patients in sustained LDA (DAS28-CRP < 3.2 for more than 6 months) who had been receiving adalimumab plus MTX enrolled in the PRIMULA study were evaluated in this study. All patients underwent US evaluation of synovial hypertrophy (SH) and power Doppler (PD) signal presence. The joints were graded on grayscale (GS; 0-3) and power Doppler (PD; 0-3). Nineteen patients agreed to discontinue adalimumab and 12 continued. Trial visits were performed at week 13, 26, and 52. Modified total Sharp score (mTSS) was also evaluated at the enrollment and the end of study (at week 52). Relapse was defined when DAS28-CRP score elevated more than 3.2. The relationship between the integral value of each disease activity score (ESR, CRP, DAS28, SDAI, and US-SH and -PD score, etc.) and △mTSS (0-52w) was analysed.

Results:

Among the 19 discontinuation group patients, 8 cases relapsed during 1-year study period. There was no significant difference between the relapse group (n=8) and non-relapse group (n=11) in the baseline clinical composite measure (DAS28-CRP 1.3 vs. 1.3; p=0.68) and US score (GS and PD total score 3.4 vs. 3.5; p=0.64) (table 1). Only the integral value (0-52w) of CRP significantly correlated with △mTSS (0-52w) (r=0.617, p=0.006) (table 2).

Conclusion: In this study, US provided limited additional value as a tool to predict patients’ prognosis according to clinical disease activity and radiographic progression, after discontinuation of adalimumab in RA patients who achieved sustained LDA with adalimumab plus MTX.

Table 1. demographic and clinical characteristics at discontinuation

demographic and clinical characteristics

Discontinuation group

Wilcoxon rank sum test

non-relapse

relapse

n

mean

SD

n

mean

SD

age (years)

11

56.0

18.2

8

61.4

9.8

0.408

disease duration (years)

11

9.4

12.9

8

8.5

6.6

0.386

MTX dose (mg/wk)

11

8.2

1.1

8

7.8

2.7

0.567

ESR(mm/hr)

11

13.1

9.0

8

13.6

6.9

0.620

CRP(mg/dl)

11

0.14

0.36

8

0.05

0.07

0.655

DAS28/4 ESR

11

1.7

0.6

8

1.9

0.4

0.364

DAS28/4 CRP

11

1.3

0.3

8

1.3

0.2

0.679

SDAI

11

1.2

0.6

8

2.1

1.3

0.230

CDAI

11

1.1

0.7

8

2.0

1.3

0.159

US total

11

3.5

3.5

8

3.4

4.7

0.643

US GS

11

2.0

1.9

8

2.0

3.0

0.583

US DP

11

1.5

1.8

8

1.4

1.7

0.863

MMP-3(ng/ml)

11

85.5

106.5

8

42.0

13.1

0.591

RF

6

72.7

101.8

2

84.5

21.9

0.317

body weight (kg)

10

50.9

7.3

8

51.9

5.3

0.755

Erosion

6

28.1

67.3

4

15.4

12.5

0.084

JSN

6

21.5

45.9

4

12.9

10.3

0.392

mTSS

6

49.6

113.2

4

28.2

22.4

0.201

Table 2. Correlation between each integral value and △TSS

N

Pearson’s correlation

R

Prob.

US total

17

0.392

0.120

US GS

17

0.272

0.290

US PD

17

0.385

0.127

ESR

18

0.204

0.417

CRP

18

0.617

0.006

DAS28ESR

18

0.009

0.971

DAS28CRP

18

0.256

0.306

SDAI

18

0.274

0.272

CDAI

18

0.028

0.912

Disclosure: K. Amano, Abbvie, 5,Pfizer Inc, 5,Tanabe-Mitsubishi Pharma, 5,Astellas, 5,Janssen Pharmaceutica Product, L.P., 5,Daiichi-Sankyo, 5,Chugai, 5; K. Aoki, Abbvie, 5; Y. Kuga, Abbvie, 5; K. Nishimura, None; H. Nagasawa, None; T. T. Wada, None; K. Takagi, None; J. Hayashi, None; M. Kaneko, None; R. Sakai, None; A. Shibata, None; K. Chino, None; S. Saito, None; A. Okuyama, None; T. Kondo, None; H. Takei, None; T. Mimura, Abbvie, 5,Astellas, 5,Eisai, 5,Janssen Pharmaceutica Product, L.P., 5,Novartis Pharmaceutical Corporation, 5,Ono Pharma, 5,Pfizer Inc, 5,Sanofi-Aventis Pharmaceutical, 5,Takeda Pharmaceutical, 5,Tanabe-Mitsubishi Pharma, 5.

To cite this abstract in AMA style:

Amano K, Aoki K, Kuga Y, Nishimura K, Nagasawa H, Wada TT, Takagi K, Hayashi J, Kaneko M, Sakai R, Shibata A, Chino K, Saito S, Okuyama A, Kondo T, Takei H, Mimura T. Prospective Study of Bio-Free Remission Maintenance Using Ultrasonography in Rheumatoid Arthritis Patients: 52-Week Result [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/prospective-study-of-bio-free-remission-maintenance-using-ultrasonography-in-rheumatoid-arthritis-patients-52-week-result/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/prospective-study-of-bio-free-remission-maintenance-using-ultrasonography-in-rheumatoid-arthritis-patients-52-week-result/