Table 3

Results of the primary outcome at 6 months and differences in both groups in secondary outcomes between baseline and 6 months

Control group (n=63)Intervention group (n=64)Between-group difference (95% CI)P value
n*n*
Primary outcome
BioSecure score† at 6 months, mean (SD)6375.6 (13.0)6481.2 (13.1)5.6 (1.1 to 10.2)0.016‡
Secondary outcomes
DAS28§ difference (6 months–BL), mean (SD)12−1.3 (1.7)20−1.9 (1.3)(−0.88 to 0.50)0.5850¶
BASDAI§ difference (6 months–BL) (0–10), mean (SD)43−1.1 (1.8)38−1.6 (2.1)(−1.29 to 0.42)0.3211¶
ASDAS§ difference (6 months–BL), median (IQR)39−0.7 (−1.5 to 0.0)32−0.7 (−1.7 to −0.1)0.8448**
Coping§ difference (6 months–BL) (0–10), mean (SD)58−0.7 (2.8)57−1.9 (2.3)(−1.80 to −0.11)0.0275¶
Psychological well-being§ difference (6 months–BL) (0–10), mean (SD)58−1.0 (3.0)57−1.4 (2.4)(−1.40 to 0.36)0.2453¶
AHI§ score difference (6 months–BL) (5–20), mean (SD)48−1.2 (2.6)45−1.4 (3.0)(−1.29 to 0.72)0.5702¶
BMQ necessity† difference (6 months–BL) (5–25), mean (SD)460.2 (3.8)490.5 (3.4)(−0.85 to 1.72)0.5001¶
BMQ concerns§ score difference (6 months–BL) (5–25), mean (SD)49−1.0 (3.5)48−1.5 (4.8)(−2.12 to 0.78)0.3623¶
Severe infections†† within 6 months, n (%)611 (1.6)580 (0)1.0000‡‡

  • *Number of available data.

  • †High score indicates good score.

  • ‡Student’s t-test.

  • §High score indicates poor score.

  • ¶Linear regression adjusted on the initial score value.

  • **Wilcoxon test.

  • ††Infections requiring hospitalisation or intravenous antibiotics.

  • ‡‡Fisher’s exact test.

  • AHI, Arthritis Helplessness Index; ASAS, Assessment of SpondyloArthritis international Society; ASDAS, ASAS-endorsed Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BL, Baseline; BMQ, Beliefs About Medication Questionnaire; DAS28, Disease Activity Score in 28 joints.