|
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
|
- Ankylosing Spondylitis Disease Activity Score including C-reactive protein (ASDAS-CRP) relapse was defined by increase ≥ 1.1. Bath Ankylosing Spondylitis Disease Activity Index-visual analogue scale (BASDAI-VAS) was defined by increases of 20% or a 2-unit increase in the 0–10 scale. SER relapse was defined by BASDAI ≥ 4, global clinical assessment by physician ≥ 4 and at least one of three following criteria: patient assessment ≥ 4, axial nocturnal pain (VAS) ≥ 4, and increase in acute phase reactants (reactive °C protein (PCR) and/or erythrocyte sedimentation rate (ESR). Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-C), which is calculated as (0.12 x back pain) + (0.06 x duration of morning stiffness) + (0.11 x patient GA) + (0.07 x peripheral pain/swelling) + (0.58 x Ln(CRP + 1)); if CRP is not available but ESR is available, the last term is changed by (0.29 x √(ESR)). BASDAI is calculated as {A + B + C + D+ [(E + F)/2]}/5 where A to E are 6 VAS, rated 0 (best) to 10 (worst) assessing (A) fatigue, (B) axial skeletal pain, (C) peripheral joint pain, (D) pain on contact or pressure, (E) intensity of morning stiffness and (F) duration of morning stiffness; VAS nocturnal axial pain is the patient’s rating of nocturnal pain by VAS ranging from 0 (none) to 10 (worst). Patient Global Assessment (PGA) of disease activity was rated from 0 (best) to 10 (worst). Investigator’s Global Assessment (IGA) of disease activity was rated from 0 (best) to 10 (worst). The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the average value of answers to 10 questions rated from 0 (best) to 10 (worst). Ankylosing Spondylitis Quality of Life (ASQoL - Spanish validated version) scores from 0 to 18, where lower scores indicate better health-related quality of life. Adverse event (AE) or infection presented as proportion (95% CI) of patients with at least one reported adverse event and/or infection; related presented as proportion (95% CI) of patients with at least one reported AE and/or infection assessed by the investigator as at least possibly related to TNF inhibitor (TNFi) treatment; severe presented as proportion (95% CI) of patients with at least one severe reported AE and/or infection according to standard definitions (fatal or life-threatening, required or prolonged the patient’s hospitalization, caused significant or persistent disability, caused congenital anomaly/birth defect or required immediate medical intervention to avoid any of the previous outcomes); severe and related presented as proportion (95% CI) of patients with at least one reported severe and related AE and/or infection. SER: Spanish Society of Rheumatology (Sociedad Española de Reumatología)
- aAdjusted percentage estimates [95% CI], binomial regression
- bAdjusted least square means (standard error of the mean) [95% CI], mixed model for repeated measurements cNumber (%) [95CI]), analyzed by Fisher’s exact test
