Table 1

Efficacy data until week 108 in the groups who reached remission and showed a flare of the disease (groups A and B) and in the non-remission groups (groups C and D)

Remission-flare groupNon-remission group
ParameterStudy time pointETA year 1–ETA year 2 (n=9), group ASSZ year 1–ETA year 2 (n=3), group BETA year 1–ETA year 2 (n=22), group CSSZ year 1–ETA year 2 (n=26), group D
BASDAI (0–10)Baseline5.7 (1.8)5.9 (1.6)5.4 (1.1)5.9 (1.2)
Week 481.1 (0.6)2.0 (1.0)2.6 (1.7)4.7 (2.3)
Flare time point5.0 (1.5)*4.5 (0.4)NANA
Week 1081.5 (1.4)*1.7 (1.6)2.7 (2.3)3.2 (2.6)
ASDASBaseline3.9 (1.0)3.5 (0.8)3.3 (0.7)3.4 (0.6)
Week 481.3 (0.4)1.7 (0.2)1.8 (0.7)2.7 (0.9)
Flare time point2.9 (1.1)*2.5 (1.2)NANA
Week 1081.2 (0.6)*1.6 (1.3)1.9 (1.1)2.0 (1.0)
CRP (mg/l)Baseline21.4 (19.6)9.8 (10.4)10.0 (10.9)8.4 (12.3)
Week 484.0 (2.3)4.8 (3.2)4.8 (4.7)5.4 (6.0)
Flare time point10.4 (15.2)8.3 (9.4)NANA
Week 1082.2 (2.3)9.2 (11.6)5.9 (6.2)6.8 (13.7)
MRI SIJ (0–16)Baseline12.0 (6.4)3.2 (3.9)8.6 (7.3)6.5 (5.8)
Week 481.1 (1.4)0 (0)2.4 (3.3)2.7 (3.2)
Week 1080.4 (0.5)0 (0)2.9 (3.7)1.6 (2.0)
MRI spine (0–69)Baseline0.2 (0.7)0.7 (1.2)3.4 (5.6)1.3 (2.5)
Week 480 (0)0 (0)1.3 (1.9)1.0 (1.9)
Week 1080 (0)0.3 (0.6)1.0 (1.7)0.7 (1.6)
MRI enthesitisBaseline5 sites (in 4 patients)1 site (in 1 patient)16 sites (in 7 patients)11 sites (in 8 patients)
Week 481 site (in 1 patient)1 site (in 1 patient)12 sites (in 3 patients)7 sites (in 4 patients)
Week 1080 sites (in 0 patients)1 site (in 1 patient)4 sites (in 3 patients)6 sites (in 4 patients)
ASAS remissionWeek 10856% (5/9)66.7% (2/3)50% (11/22)23.1% (6/26)
MRI remissionWeek 10844.4% (4/9)66.7% (2/3)15.8% (3/22)23.1% (6/26)
Study remission (ASAS plus MRI remission)Week 10833.3% (3/9)33.3% (1/3)14% (3/22)7.7% (2/26)
  • Data for BASDAI, ASDAS, CRP, MRI SI joint score and MRI spine are presented as mean values (SD).

  • Data for patients reaching ASAS remission, MRI remission (no active inflammatory lesions on MRI of the SIJ and spine) and study remission (=ASAS remission plus MRI remission) at week 108 are presented as percentage (number).

  • * Change between flare value and week 108 value is statistically significant with p value <0.05.

  • No additional MRI was performed at the flare time point.

  • Only active osteitis (hyperintense bone signal in the STIR sequence) was scored as enthesitis.

  • ASAS, Assessment of Spondyloarthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C reactive protein; ETA, etanercept; MRI SIJ, MRI sacroiliac joint score; NA, not applicable; SSZ, sulfasalazine.