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Table 3 Comparison of biomarker levels based on a 50% reduction in the BASDAI index and ASDAS criteria from baseline to week 12 or week 24 in the DANISH and ASIM studies, respectively

From: Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis—results from two randomized controlled trials

Biomarker

Baseline

After treatmenta

DANISH

ASIM

DANISH

ASIM

BASDAI R vs NR

ASDAS CII vs NI

ASDAS MI vs NI

ASDAS ≥ CII vs NI

BASDAI R vs NR

ASDAS CII vs NI

ASDAS MI vs NI

ASDAS ≥ CII vs NI

BASDAI R vs NR

ASDAS CII vs NI

ASDAS MI vs NI

ASDAS ≥ CII vs NI

BASDAI R vs NR

ASDAS CII vs NI

ASDAS MI vs NI

ASDAS ≥ CII vs NI

C1M

1.43 [0.99, 2.07]

1.43 [0.94, 2.18]

2.79 [1.85, 4.19]§

2.04 [1.39, 3.0]‡

1.46 [0.93, 2.3]

1.18 [0.71, 2.0]

1.90 [1.19, 3.0]

1.58 [1.03, 2.4]

0.79 [0.54, 1.16]

0.77 [0.51, 1.18]

0.79 [0.52, 1.19]

0.78 [0.53, 1.1]

0.88 [0.56, 1.4]

0.92 [0.55, 1.5]

0.94 [0.59, 1.5]

0.93 [0.60, 1.4]

C3M

1.07 [0.94, 1.21]

1.13 [0.97, 1.32]

1.29 [1.11, 1.50]†

1.21 [1.06, 1.4]†

1.04 [0.89, 1.2]

0.99 [0.83, 1.2]

1.06 [0.91, 1.2]

1.03 [0.89, 1.2]

0.92 [0.81, 1.04]

1.02 [0.87, 1.19]

0.96 [0.82, 1.11]

0.99 [0.86, 1.1]

0.97 [0.83, 1.1]

1.05 [0.88, 1.3]

0.93 [0.80, 1.1]

0.98 [0.84, 1.1]

C4M

1.14 [0.99, 1.32]

1.14 [0.97, 1.35]

1.47 [1.25, 1.72]§

1.31 [1.13, 1.5]‡

1.04 [0.88, 1.2]

0.99 [0.81, 1.2]

1.11 [0.93, 1.3]

1.06 [0.90, 1.2]

0.94 [0.81, 1.08]

0.91 [0.77, 1.07]

0.98 [0.84, 1.15]

0.95 [0.82, 1.1]

0.90 [0.76, 1.1]

0.98 [0.80, 1.2]

0.90 [0.75, 1.1]

0.93 [0.79, 1.1]

C6M

1.09 [0.91, 1.30]

1.21 [0.98, 1.49]

1.54 [1.25, 1.89]‡

1.37 [1.14, 1.7]‡

1.27 [1.03, 1.6]

1.25 [0.99, 1.6]

1.24 [1.00, 1.5]

1.24 [1.02, 1.5]

0.90 [0.75, 1.08]

1.00 [0.81, 1.24]

1.00 [0.82, 1.23]

1.00 [0.83, 1.2]

1.04 [0.84, 1.3]

1.14 [0.89, 1.4]

0.99 [0.79, 1.2]

1.04 [0.85, 1.3]

CRP

1.83 [0.99, 3.38]

1.48 [0.76, 2.89]

6.83 [3.58,13.06]§

3.35 [1.77, 6.3]‡

2.50 [0.84, 7.4]

1.33 [0.37, 4.7]

3.65 [1.16,11.5]

2.47 [0.86, 7.1]

0.70 [0.37, 1.31]

0.78 [0.40, 1.52]

0.89 [0.46, 1.69]

0.83 [0.44, 1.6]

0.71 [0.24, 2.1]

0.95 [0.27, 3.4]

0.78 [0.25, 2.5]

0.85 [0.29, 2.4]

CRPM

1.22 [1.01, 1.48]

1.00 [0.77, 1.28]

1.30 [1.02, 1.66]

1.15 [0.92, 1.4]

1.16 [0.87, 1.5]

1.03 [0.73, 1.4]

1.10 [0.81, 1.5]

1.07 [0.81, 1.4]

0.99 [0.82, 1.20]

0.92 [0.72, 1.18]

0.95 [0.75, 1.22]

0.94 [0.75, 1.2]

0.94 [0.70, 1.3]

0.94 [0.67, 1.3]

0.96 [0.70, 1.3]

0.95 [0.72, 1.3]

PROM

0.80 [0.63, 1.03]

1.08 [0.78, 1.49]

0.88 [0.65, 1.21]

0.97 [0.73, 1.3]

1.08 [0.84, 1.4]

1.13 [0.84, 1.5]

1.35 [1.03, 1.8]

1.26 [0.98, 1.6]

0.75 [0.58, 0.96]

1.01 [0.73, 1.40]

0.78 [0.57, 1.07]

0.88 [0.67, 1.2]

0.97 [0.75, 1.3]

1.05 [0.78, 1.4]

1.19 [0.91, 1.6]

1.14 [0.89, 1.5]

VICM

1.28 [0.85, 1.92]

1.04 [0.61, 1.76]

1.82 [1.10, 3.01]

1.41 [0.90, 2.2]

1.22 [0.82, 1.8]

1.30 [0.83, 2.0]

1.16 [0.77, 1.7]

1.21 [0.83, 1.8]

0.95 [0.62, 1.45]

0.74 [0.43, 1.25]

0.93 [0.56, 1.53]

0.84 [0.53, 1.3]

1.06 [0.71, 1.6]

1.38 [0.88, 2.2]

0.93 [0.61, 1.4]

1.08 [0.73, 1.6]

CPa9-HNE

1.20 [0.81, 1.79]

0.72 [0.46, 1.12]

1.28 [0.83, 1.96]

0.98 [0.66, 1.5]

1.43 [0.96, 2.2]

1.36 [0.85, 2.2]

1.38 [0.90, 2.1]

1.38 [0.93, 2.0]

1.02 [0.68, 1.53]

0.59 [0.38, 0.92]

0.79 [0.51, 1.21]

0.69 [0.47, 1.0]

1.05 [0.69, 1.6]

1.14 [0.70, 1.8]

0.97 [0.63, 1.5]

1.03 [0.69, 1.5]

C2M

1.07 [0.83, 1.37]

0.89 [0.63, 1.24]

1.13 [0.82, 1.56]

1.01 [0.76, 1.3]

1.14 [0.97, 1.3]

1.16 [0.96, 1.4]

1.12 [0.94, 1.3]

1.14 [0.97, 1.3]

0.85 [0.66, 1.10]

0.80 [0.57, 1.12]

0.84 [0.61, 1.16]

0.82 [0.62, 1.1]

1.07 [0.90, 1.3]

1.11 [0.91, 1.4]

1.04 [0.87, 1.2]

1.07 [0.90, 1.3]

T2CM

0.88 [0.72, 1.07]

1.05 [0.80, 1.37]

0.93 [0.72, 1.21]

0.98 [0.78, 1.2]

0.99 [0.85, 1.1]

0.99 [0.83, 1.2]

1.00 [0.85, 1.2]

1.00 [0.86, 1.2]

0.87 [0.71, 1.06]

1.06 [0.81, 1.38]

0.85 [0.66, 1.10]

0.94 [0.75, 1.2]

0.99 [0.85, 1.2]

1.04 [0.87, 1.2]

0.96 [0.81, 1.1]

0.99 [0.85, 1.1]

C10C

1.06 [0.94, 1.18]

0.98 [0.84, 1.13]

1.02 [0.88, 1.17]

1.00 [0.88, 1.1]

1.03 [0.87, 1.2]

1.14 [0.93, 1.4]

1.08 [0.89, 1.3]

1.10 [0.93, 1.3]

1.05 [0.94, 1.18]

1.04 [0.90, 1.20]

1.08 [0.94, 1.24]

1.06 [0.94, 1.2]

0.99 [0.83, 1.2]

1.04 [0.84, 1.3]

1.02 [0.85, 1.2]

1.03 [0.87, 1.2]

PRO-C3

0.97 [0.86, 1.09]

1.11 [0.97, 1.27]

1.02 [0.90, 1.17]

1.06 [0.94, 1.2]

0.86 [0.75, 1.0]

0.91 [0.76, 1.1]

0.87 [0.74, 1.0]

0.88 [0.76, 1.0]

0.98 [0.87, 1.11]

1.03 [0.89, 1.18]

1.03 [0.90, 1.18]

1.03 [0.92, 1.2]

0.89 [0.76, 1.0]

0.93 [0.78, 1.1]

0.91 [0.78, 1.1]

0.92 [0.79, 1.1]

PRO-C4

1.02 [0.94, 1.09]

1.08 [0.98, 1.19]

1.10 [1.00, 1.21]

1.09 [1.00, 1.2]

1.12 [1.02, 1.2]

1.10 [0.99, 1.2]

1.14 [1.03, 1.3]

1.13 [1.03, 1.2]†

0.97 [0.90, 1.05]

1.03 [0.93, 1.14]

1.01 [0.92, 1.12]

1.02 [0.94, 1.1]

1.00 [0.91, 1.1]

1.02 [0.92, 1.1]

1.01 [0.91, 1.1]

1.01 [0.93, 1.1]

PRO-C6

0.93 [0.80, 1.09]

0.97 [0.78, 1.20]

1.01 [0.82, 1.24]

0.99 [0.83, 1.2]

0.95 [0.82, 1.1]

1.02 [0.85, 1.2]

1.02 [0.86, 1.2]

1.02 [0.88, 1.2]

0.90 [0.77, 1.05]

0.97 [0.78, 1.20]

0.96 [0.78, 1.18]

0.96 [0.80, 1.2]

0.90 [0.77, 1.0]

0.93 [0.78, 1.1]

0.95 [0.81, 1.1]

0.95 [0.81, 1.1]

PRO-C2

0.91 [0.72, 1.14]

1.09 [0.80, 1.49]

0.98 [0.72, 1.32]

1.03 [0.79, 1.3]

1.17 [0.79, 1.7]

1.02 [0.65, 1.6]

1.21 [0.80, 1.8]

1.13 [0.78, 1.7]

0.91 [0.72, 1.14]

0.99 [0.73, 1.36]

1.00 [0.74, 1.36]

1.00 [0.77, 1.3]

1.16 [0.79, 1.7]

0.98 [0.62, 1.5]

1.25 [0.83, 1.9]

1.14 [0.78, 1.7]

  1. Data are presented as the ratio of average serum biomarker levels with 95% CI between the groups. p-values were adjusted for multiple comparisons by the false rate discovery method, and significance is shown as †p < 0.05, ‡p < 0.01, and §p < 0.001
  2. Abbreviations: BASDAI Bath Ankylosing Spondylitis Disease Activity Index, R responder, NR non-responder, ASDAS Assess Disease Activity in Ankylosing Spondylitis, MI major improvement, CII clinically important improvement, NI no improvement, C1M metalloproteinase (MMP)-2/9/13-degraded type I collagen, C3M MMP-degraded type III collagen, C4M MMP (multiple)-degraded type IV collagen, C6M MMP-2/9-degraded type VI collagen, CRP C-reactive protein, CRPM C-reactive protein metabolite, PROM MMP-1- and MMP-13-mediated degradation of prolargin, VICM citrullinated and MMP-degraded vimentin, CPa9-HNE HNE-mediated degradation of calprotectin, C2M MMP (multiple)-degraded type II collagen, T2CM MMP-1/13-mediated degradation of type II collagen, C10C cathepsin-K-mediated degradation of type X collagen, PRO-C3 pro-peptide of type III collagen, PRO-C4 type IV 7S domain collagen, PRO-C6 type VI alpha-3 chain collagen, PRO-C2 pro-peptide of type II collagen
  3. aResponse to treatment was considered after 12 or 24 weeks of treatment (DANISH and ASIM, respectively). In the DANISH study, data from the placebo group at week 12 was considered baseline, and data from week 24 was considered as week 12 of treatment
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Arthritis Research & Therapy

ISSN: 1478-6362

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