A total of 517 patients consisted of 507 in Group-1 and 517 in Group-2, including 414 in Group-same1PGA, 93 in Group-step1PGA, and 10 in Group-2PGA. 73.2% in Group-1 and 72.7% in Group-2 were female, compared with 72.2% in Group-same1PGA, 77.4% in Group-step1PGA, and 50.0% in Group-2PGA. Mean age at baseline was 65.6 and 65.7 years for Group-1 and Group-2, respectively, whereas it was 65.7, 65.1 and 70.0 years for Group-same1PGA, Group-step1PGA, and Group-2PGA, respectively. The demographic and clinical characteristics at baseline and initial visit were as shown in Table 1.
Table 1
Demographic and clinical characteristics of groups
|
|
Group-1 (n = 507)
|
Group-same1PGA (n = 414)
|
Group-step1PGA (n = 93)
|
Group-2PGA (n = 10)
|
Group-2 (n = 517)
|
|
female (%)
|
73.2
|
72.2
|
77.4
|
50.0
|
72.7
|
at first consult
|
age (years)
|
64.3 (13.9)
|
64.6 (14.1)
|
63.5 (13.1)
|
70.0 (19.2)
|
64.5 (14.1)
|
disease duration (years)
|
6.2 (8.1)
|
6.7 (8.6)
|
4.3 (5.1)
|
6.2 (9.0)
|
6.2 (8.1)
|
ACPA positive rate (%)
|
80.1
|
81.2
|
75.7
|
55.0
|
79.6
|
RF positive rate (%)
|
77.3
|
77.4
|
76.7
|
65.0
|
77.0
|
SDAI
|
22.0 (21.8)
|
21.6 (21.8)
|
23.6 (21.7)
|
19.3 (18.2)
|
22.0 (21.8)
|
HAQ-DI
|
0.463 (0.578)
|
0.457 (0.580)
|
0.489 (0.568)
|
0.700 (0.731)
|
0.468 (0.582)
|
PS-VAS
|
34.1 (29.1)
|
33.0 (29.8)
|
39.1 (25.0)
|
40.4 (19.3)
|
34.2 (28.9)
|
SHS
|
46.9 (62.2)
|
48.5 (65.6)
|
39.6 (43.3)
|
57.3 (91.1)
|
47.1 (62.9)
|
|
time span from first consultation to Boolean-1 (months)
|
14.9 (14.6)
|
13.9 (14.2)
|
19.1 (16.1)
|
|
14.7 (14.4)
|
|
time span from first consultation to Boolean-2 (months)
|
13.0 (13.1)
|
13.9 (14.2)
|
9.2 (7.2)
|
7.8 (6.4)
|
12.9 (12.9)
|
|
time span from Boolean-2 to Boolean-1 (months)
|
1.9 (1.4)
|
0.0
|
9.9 (8.8)
|
|
1.9 (1.4)
|
|
average MTX dosage by Boolean-1 (mg/week)
|
8.0 (2.6)
|
7.9 (2.6)
|
8.2 (2.8)
|
|
8.0 (2.6)
|
|
average MTX dosage by Boolean-2 (mg/week)
|
7.9 (2.6)
|
7.9 (2.6)
|
8.1 (2.7)
|
7.4 (2.5)
|
7.9 (2.6)
|
|
GCS administration rate by Boolean-1 (%)
|
35.7
|
35.0
|
38.7
|
|
35.0
|
|
GCS administration rate by Boolean-2 (%)
|
35.1
|
35.0
|
35.5
|
30.0
|
35.0
|
|
SDAI at Boolean-1
|
1.07 (1.04)
|
1.07 (1.07)
|
1.06 (0.90)
|
|
1.07 (1.07)
|
|
SDAI at Boolean-2
|
1.43 (1.35)
|
1.07 (1.07)
|
3.06 (1.28)
|
2.97 (1.17)
|
1.46 (1.37)
|
|
HAQ-DI at Boolean-1
|
0.416 (0.569)
|
0.410 (0.564)
|
0.440 (0.588)
|
|
0.416 (0.574)
|
|
HAQ-DI at Boolean-2
|
0.415 (0.564)
|
0.410 (0.564)
|
0.435 (0.564)
|
0.700 (0.731)
|
0.421 (0.569)
|
|
PS-VAS at Boolean-1
|
15.3 (20.5)
|
14.9 (20.3)
|
17.5 (21.1)
|
|
15.3 (20.5)
|
|
PS-VAS at Boolean-2
|
15.5 (19.4)
|
14.9 (20.3)
|
18.6 (14.0)
|
27.4 (16.4)
|
15.8 (19.4)
|
The values are presented as mean (SD) unless indicated otherwise.
Group-1: a patient group who attained Boolean remission with all of tenderness joint count (TJC), swollen joint count (SJC), patient's global assessment (PGA), and serum C-reactive protein level (CRP) ≤ 1 (Boolean-1) during follow up ; Group-2, a patient group who attained Boolean near remission with TJC, SJC, CRP ≤ 1, and PGA ≤ 2 (Boolean-2) during follow up ; Group-same1PGA, a patient group who attained Boolean-1 and Boolean-2 at the same time ; Group-step1PGA, a patient group who attained Boolean-2 first and then achieved Boolean-1 ; Group-2PGA, a patient group who attained Boolean-2 but not attained Boolean-1. Abbreviations: ACPA, anti-citrullinated polypeptide antibodies ; RF, rheumatoid factor ; SDAI, simplified disease activity index ; HAQ-DI, Health Assessment Questionnaire Disability Index ; PS-VAS, pain score with visual analog scale ; SHS, Sharp/van der Heijde score ; MTX, methotrexate ; GCS, glucocorticoid steroid.
|
Mean SDAI scores in Group-1 for Boolean-1 and in Group-2 for Boolean-2 were 1.07 and 1.46, 3.78 and 3.94, and 3.89 and 4.16 at baseline, 6 months after, and 1 year after, respectively. Mean SDAI score at baseline in Group-1 was significantly smaller than in Group-2. Mean HAQ scores in Group-1 for Boolean-1 and in Group-2 for Boolean-2 were 0.400 and 0.403, 0.388 and 0.396, and 0.390 and 0.400 at baseline, 6 months after, and 1 year after, respectively. Mean PS-VAS in Group-1 for Boolean-1 and in Group-2 for Boolean-2 were 15.3 and 15.7, 20.6 and 21.1, and 21.6 and 22.2, at baseline, 6 months after, and 1 year after, respectively. There were no significant differences between the two groups in either HAQ score or PS-VAS (Fig. 1).
On the other hand, mean SDAI scores in Group-same1PGA and Group-step1PGA were 1.07 and 1.06, 3.62 and 4.51, and 4.02 and 3.31 at baseline, 6 months after, and 1 year after Boolean-1, respectively. Mean SDAI score at 6 months after in Group-same1PGA was significantly smaller than in Group-step1PGA. Mean SDAI scores in Group-same1PGA, Group-step1PGA, and Group-2PGA were 1.07, 3.06, and 2.97, 3.62, 4.73, and 10.08, and 4.02, 4.39, and 7.75 at baseline, 6 months after, and 1 year after the Boolean-2, respectively. Mean SDAI score in Group-same1PGA was significantly lower than in Group-step1PGA and Group-2PGA at any time point, but the mean SDAI score in Group-step1PGA at 6 months after was significantly lower than in Group-2PGA (Fig. 2-A). Although the mean SDAI score at baseline was significantly lower in the Group-2PGA than at 6 and 12 months (p < 0.0001), the SDAI scores of the other groups at 6 and 12 months did not show a significant increase from baseline, there was a common trend in all groups that the mean SDAI score increased from baseline to the following period.
Mean HAQ scores in Group-same1PGA and Group-step1PGA were 0.410 and 0.440, 0.393 and 0.417, and 0.396 and 0.413, at baseline, 6 months after, and 1 year after Boolean-1, respectively. There was no significant difference between the two groups. Mean HAQ scores in Group-same1PGA, Group-step1PGA, and Group-2PGA were 0.410, 0.435, and 0.700, 0.393, 0.423, and 0.725, and 0.396, 0.425, and 0.725 at baseline, 6 months after, and 1 year after the Boolean-2, respectively. Mean HAQ scores of Group-2PGA were relatively greater compared to that of Group-same1PGA and the Group-step1PGA, however, no the difference was not significant (Fig. 2-B).
Mean PS-VASs in Group-same1PGA and Group-step1PGA were 14.9 and 17.5, 20.3 and 21.8, and 21.4 and 22.3 at baseline, 6 months after, and 1 year after the Boolean-1, respectively. There was no significant difference between the two groups. Mean PS-VASs in Group-same1PGA, Grpup-step1PGA, and Group-2PGA were 14.9, 18.6, and 27.4, 20.3, 22.1, and 42.9 at baseline, 6 months after, and 1 year after the Boolean-2, respectively. Mean PS-VAS of Group-same1PGA were significantly lower than that of Group-step1PGA at baseline of the Boolean-2, whereas mean PS-VAS of Group-step1PGA was significantly lower than that of Group-2PGA at 6 months after the Boolean-2. PS-VASs of Group-same1PGA were significantly lower than that of Group-2PGA (Fig. 2-C).