Efficacy secondary variables at 1 year | ||||
Variables | Full dose (n = 55) | Dose reduction (n = 58) | Differences between groups | P value |
ASDAS-CRP < 1.3a | 61.4% [47.3%; 75.5%] | 53.5% [39.7%; 67.3%] | 7.8% [−10.0%; 25.8%] | 0.389 |
ASDAS-CRP relapsea | 6.6% [−5.4%; 18.7%] | 12.7% [1.4%; 24.0%] | −6.1% [−25.2%; 12.9%] | 0.529 |
Relapse BASDAI-VASa | 15.9% [−3.1%; 34.9%] | 10.4% [−9.1%; 29.8%] | 5.5% [−12.3%; 23.4%] | 0.545 |
Relapse SERa | 6.4% [−13.0%; 25.8%] | 10.1% [−7.9%; 28.1%] | − 3.7% [− 19.2%; 11.8%] | 0.638 |
NSAIDs usea | 18.3% [− 1.2%; 37.7%] | 20.6% [1.5%; 39.8%] | −2.4% [− 18.9%; 14.2%] | 0.779 |
ASDAS-CRP scoreb | 1.1 (0.1) [0.9;1.3] | 1.1 (0.1) [0.9;1.3] | 0.0 (0.2) [−0.3;0.3] | 0.783 |
BASDAIb | 1.4 (0.2) [1.1;1.7] | 1.4 (0.2) [1.1;1.7] | − 0.0 (0.2) [− 0.5;0.4] | 0.890 |
VAS night axial painb | 1.4 (0.2) [1.0;1.8] | 1.1 (0.2) [0.7;1.6] | 0.3 (0.3) [−0.3;0.9] | 0.337 |
PGAb | 1.6 (0.2) [1.2;2.0] | 1.6 (0.2) [1.1;2.0] | 0.0 (0.3) [−0.6;0.6] | 0.962 |
IGAb | 1.1 (0.2) [0.8;1.4] | 1.1 (0.2) [0.8;1.4] | −0.0 (0.2) [− 0.4;0.40] | 0.923 |
BASFIb | 1.7 (0.2) [1.2;2.1] | 1.8 (0.2) [1.3;2.3] | −0.2 (0.3) [− 0.8;0.5] | 0.616 |
ASQoLb | 2.3 (0.5) [1.2;3.3] | 2.2 (0.6) [1.0;3.3] | 0.1 (0.7) [−1.3;1.5] | 0.858 |
Safety secondary variables | ||||
Adverse event or infections | Full dose (n = 62) | Dose reduction (n = 61) | Differences between groups | P value |
Anyc | 22 (35.5%) [23.6%;47.4%] | 17 (27.9%) [16.6%;39.1%] | (7.6%) [−8.8%;24.0%] | 0.439 |
Relatedc | 8 (12.9%) [4.6%;21.2%] | 5 (8.2%) [1.3%;15.1%] | (4.7%) [−6.1%;15.5%] | 0.559 |
Severec | 14 (22.6%) [12.2%;33.0%] | 11 (18.0%) [8.4%;27.7%] | (4.6%) [−9.6%;18.7%] | 0.655 |
Severe and relatedc | 7 (11.3%) [3.4%;19.2%] | 2 (3.3%) [−1.2%;7.7%] | (8%) [− 1.1%;17.1%] | 0.164 |