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Table 3 Secondary endpoints

From: Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis

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
  1. 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)
  2. aAdjusted percentage estimates [95% CI], binomial regression
  3. bAdjusted least square means (standard error of the mean) [95% CI], mixed model for repeated measurements cNumber (%) [95CI]), analyzed by Fisher’s exact test