Table 5

Discrimination, sensitivity to change

ANOVA between ASDAS-change scores by global rating of change category (N = 303a)
SMD in ASDAS-change scores between treatment and placebo arm (N = 235b)
Much better [mean (s.d.)]Better [mean (s.d.)]Unchanged [mean (s.d.)]Worse [mean (s.d.)]Much worse [mean (s.d.)]F-testTreatment [mean (s.d.)]Placebo [mean (s.d.)]SMD
Number of patients per category8411660251816768
Original-ASDAS−2.32 (1.00)−1.21 (0.89)−0.56 (0.89)−0.74 (1.12)−0.28 (0.84)41.72−1.91 (1.28)−1.01 (1.10)−0.75
ASDAS-Q1−2.10 (0.91)−1.07 (0.84)−0.49 (0.80)−0.77 (1.02)−0.33 (0.73)39.58−1.74 (1.18)−0.94 (0.97)−0.73
ASDAS-Q2−2.26 (0.99)−1.17 (0.89)−0.50 (0.86)−0.73 (1.06)−0.33 (0.81)41.82−1.88 (1.26)−1.03 (1.02)−0.76
ASDAS-Q14−2.19 (0.96)−1.14 (0.86)−0.51 (0.81)−0.80 (1.04)−0.34 (0.74)40.78−1.82 (1.22)−0.98 (1.03)−0.74
ASDAS-Q23−2.21 (0.99)−1.15 (0.90)−0.51 (0.87)−0.78 (1.06)−0.33 (0.79)38.29−1.85 (1.26) |−1.01 (1.05)−0.72
ASDAS-Q26−2.27 (1.01)−1.20 (0.88)−0.51 (0.84)−0.77 (1.07)−0.33 (0.84)41.31−1.89 (1.25)−1.02 (1.03)−0.76
ASDAS-Q145−2.24 (0.97)−1.18 (0.88)−0.52 (0.83)−0.83 (1.06)−0.34 (0.78)41.14−1.87 (1.24)−1.01 (1.04)−0.75
ASDAS-Q236−2.26 (1.01)−1.18 (0.90)−0.52 (0.86)−0.80 (1.08)−0.34 (0.83)39.32−1.89 (1.27)−1.03 (1.06)−0.73
ASDAS-BT−2.27 (1.00)−1.18 (0.89)−0.52 (0.85)−0.84 (1.07)−0.35 (0.80)40.34−1.89 (1.26)−1.03 (1.06)−0.74
ASDAS-C3−2.28 (0.96)−1.16 (0.93)−0.49 (0.86)−0.87 (1.05)−0.28 (0.78)42.081.89 (1.26)−1.06 (1.05)−0.72
ANOVA between ASDAS-change scores by global rating of change category (N = 303a)
SMD in ASDAS-change scores between treatment and placebo arm (N = 235b)
Much better [mean (s.d.)]Better [mean (s.d.)]Unchanged [mean (s.d.)]Worse [mean (s.d.)]Much worse [mean (s.d.)]F-testTreatment [mean (s.d.)]Placebo [mean (s.d.)]SMD
Number of patients per category8411660251816768
Original-ASDAS−2.32 (1.00)−1.21 (0.89)−0.56 (0.89)−0.74 (1.12)−0.28 (0.84)41.72−1.91 (1.28)−1.01 (1.10)−0.75
ASDAS-Q1−2.10 (0.91)−1.07 (0.84)−0.49 (0.80)−0.77 (1.02)−0.33 (0.73)39.58−1.74 (1.18)−0.94 (0.97)−0.73
ASDAS-Q2−2.26 (0.99)−1.17 (0.89)−0.50 (0.86)−0.73 (1.06)−0.33 (0.81)41.82−1.88 (1.26)−1.03 (1.02)−0.76
ASDAS-Q14−2.19 (0.96)−1.14 (0.86)−0.51 (0.81)−0.80 (1.04)−0.34 (0.74)40.78−1.82 (1.22)−0.98 (1.03)−0.74
ASDAS-Q23−2.21 (0.99)−1.15 (0.90)−0.51 (0.87)−0.78 (1.06)−0.33 (0.79)38.29−1.85 (1.26) |−1.01 (1.05)−0.72
ASDAS-Q26−2.27 (1.01)−1.20 (0.88)−0.51 (0.84)−0.77 (1.07)−0.33 (0.84)41.31−1.89 (1.25)−1.02 (1.03)−0.76
ASDAS-Q145−2.24 (0.97)−1.18 (0.88)−0.52 (0.83)−0.83 (1.06)−0.34 (0.78)41.14−1.87 (1.24)−1.01 (1.04)−0.75
ASDAS-Q236−2.26 (1.01)−1.18 (0.90)−0.52 (0.86)−0.80 (1.08)−0.34 (0.83)39.32−1.89 (1.27)−1.03 (1.06)−0.73
ASDAS-BT−2.27 (1.00)−1.18 (0.89)−0.52 (0.85)−0.84 (1.07)−0.35 (0.80)40.34−1.89 (1.26)−1.03 (1.06)−0.74
ASDAS-C3−2.28 (0.96)−1.16 (0.93)−0.49 (0.86)−0.87 (1.05)−0.28 (0.78)42.081.89 (1.26)−1.06 (1.05)−0.72

First column: ANOVA between ASDAS change scores at 12 weeks in different change statuses as defined by an external anchor (global rating of change). Second column: SMD in ASDAS change scores at 6 months in treatment vs placebo arm in the randomized controlled trials.

a

For this analysis only patients from NOR-DMARD, RAPID-axSpA database were considered, as they started a new therapy at baseline according to protocol and had an evaluation available at 12 weeks.

b

For this analysis only patients from ASSERT and RAPID-axSpA were considered, as both treatment and placebo arm were available; evaluation was performed at 6 months as available in both databases. The alternative-ASDAS formulae were calculated using, as a replacement for pGA: question 1 (Q1), Q2, average of Q1 and Q4 (Q14) or Q2 and Q3 (Q23) or Q2 and Q6 (Q26), average of questions Q1, Q4 and Q5 (Q145) or Q2, Q3 and Q6 (Q236) and total score (BT) of the BASDAI, or a constant (-C3). ASDAS: Ankylosing Spondylitis Disease Activity Scores; original-ASDAS: ASDAS according to the usual formula [5, 6]; ANOVA: analysis of variance; SMD: standardized mean differences; NOR-DMARD: Norwegian Disease-Modifying Antirheumatic Drug study; ASSERT: Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy.

Table 5

Discrimination, sensitivity to change

ANOVA between ASDAS-change scores by global rating of change category (N = 303a)
SMD in ASDAS-change scores between treatment and placebo arm (N = 235b)
Much better [mean (s.d.)]Better [mean (s.d.)]Unchanged [mean (s.d.)]Worse [mean (s.d.)]Much worse [mean (s.d.)]F-testTreatment [mean (s.d.)]Placebo [mean (s.d.)]SMD
Number of patients per category8411660251816768
Original-ASDAS−2.32 (1.00)−1.21 (0.89)−0.56 (0.89)−0.74 (1.12)−0.28 (0.84)41.72−1.91 (1.28)−1.01 (1.10)−0.75
ASDAS-Q1−2.10 (0.91)−1.07 (0.84)−0.49 (0.80)−0.77 (1.02)−0.33 (0.73)39.58−1.74 (1.18)−0.94 (0.97)−0.73
ASDAS-Q2−2.26 (0.99)−1.17 (0.89)−0.50 (0.86)−0.73 (1.06)−0.33 (0.81)41.82−1.88 (1.26)−1.03 (1.02)−0.76
ASDAS-Q14−2.19 (0.96)−1.14 (0.86)−0.51 (0.81)−0.80 (1.04)−0.34 (0.74)40.78−1.82 (1.22)−0.98 (1.03)−0.74
ASDAS-Q23−2.21 (0.99)−1.15 (0.90)−0.51 (0.87)−0.78 (1.06)−0.33 (0.79)38.29−1.85 (1.26) |−1.01 (1.05)−0.72
ASDAS-Q26−2.27 (1.01)−1.20 (0.88)−0.51 (0.84)−0.77 (1.07)−0.33 (0.84)41.31−1.89 (1.25)−1.02 (1.03)−0.76
ASDAS-Q145−2.24 (0.97)−1.18 (0.88)−0.52 (0.83)−0.83 (1.06)−0.34 (0.78)41.14−1.87 (1.24)−1.01 (1.04)−0.75
ASDAS-Q236−2.26 (1.01)−1.18 (0.90)−0.52 (0.86)−0.80 (1.08)−0.34 (0.83)39.32−1.89 (1.27)−1.03 (1.06)−0.73
ASDAS-BT−2.27 (1.00)−1.18 (0.89)−0.52 (0.85)−0.84 (1.07)−0.35 (0.80)40.34−1.89 (1.26)−1.03 (1.06)−0.74
ASDAS-C3−2.28 (0.96)−1.16 (0.93)−0.49 (0.86)−0.87 (1.05)−0.28 (0.78)42.081.89 (1.26)−1.06 (1.05)−0.72
ANOVA between ASDAS-change scores by global rating of change category (N = 303a)
SMD in ASDAS-change scores between treatment and placebo arm (N = 235b)
Much better [mean (s.d.)]Better [mean (s.d.)]Unchanged [mean (s.d.)]Worse [mean (s.d.)]Much worse [mean (s.d.)]F-testTreatment [mean (s.d.)]Placebo [mean (s.d.)]SMD
Number of patients per category8411660251816768
Original-ASDAS−2.32 (1.00)−1.21 (0.89)−0.56 (0.89)−0.74 (1.12)−0.28 (0.84)41.72−1.91 (1.28)−1.01 (1.10)−0.75
ASDAS-Q1−2.10 (0.91)−1.07 (0.84)−0.49 (0.80)−0.77 (1.02)−0.33 (0.73)39.58−1.74 (1.18)−0.94 (0.97)−0.73
ASDAS-Q2−2.26 (0.99)−1.17 (0.89)−0.50 (0.86)−0.73 (1.06)−0.33 (0.81)41.82−1.88 (1.26)−1.03 (1.02)−0.76
ASDAS-Q14−2.19 (0.96)−1.14 (0.86)−0.51 (0.81)−0.80 (1.04)−0.34 (0.74)40.78−1.82 (1.22)−0.98 (1.03)−0.74
ASDAS-Q23−2.21 (0.99)−1.15 (0.90)−0.51 (0.87)−0.78 (1.06)−0.33 (0.79)38.29−1.85 (1.26) |−1.01 (1.05)−0.72
ASDAS-Q26−2.27 (1.01)−1.20 (0.88)−0.51 (0.84)−0.77 (1.07)−0.33 (0.84)41.31−1.89 (1.25)−1.02 (1.03)−0.76
ASDAS-Q145−2.24 (0.97)−1.18 (0.88)−0.52 (0.83)−0.83 (1.06)−0.34 (0.78)41.14−1.87 (1.24)−1.01 (1.04)−0.75
ASDAS-Q236−2.26 (1.01)−1.18 (0.90)−0.52 (0.86)−0.80 (1.08)−0.34 (0.83)39.32−1.89 (1.27)−1.03 (1.06)−0.73
ASDAS-BT−2.27 (1.00)−1.18 (0.89)−0.52 (0.85)−0.84 (1.07)−0.35 (0.80)40.34−1.89 (1.26)−1.03 (1.06)−0.74
ASDAS-C3−2.28 (0.96)−1.16 (0.93)−0.49 (0.86)−0.87 (1.05)−0.28 (0.78)42.081.89 (1.26)−1.06 (1.05)−0.72

First column: ANOVA between ASDAS change scores at 12 weeks in different change statuses as defined by an external anchor (global rating of change). Second column: SMD in ASDAS change scores at 6 months in treatment vs placebo arm in the randomized controlled trials.

a

For this analysis only patients from NOR-DMARD, RAPID-axSpA database were considered, as they started a new therapy at baseline according to protocol and had an evaluation available at 12 weeks.

b

For this analysis only patients from ASSERT and RAPID-axSpA were considered, as both treatment and placebo arm were available; evaluation was performed at 6 months as available in both databases. The alternative-ASDAS formulae were calculated using, as a replacement for pGA: question 1 (Q1), Q2, average of Q1 and Q4 (Q14) or Q2 and Q3 (Q23) or Q2 and Q6 (Q26), average of questions Q1, Q4 and Q5 (Q145) or Q2, Q3 and Q6 (Q236) and total score (BT) of the BASDAI, or a constant (-C3). ASDAS: Ankylosing Spondylitis Disease Activity Scores; original-ASDAS: ASDAS according to the usual formula [5, 6]; ANOVA: analysis of variance; SMD: standardized mean differences; NOR-DMARD: Norwegian Disease-Modifying Antirheumatic Drug study; ASSERT: Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy.

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