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Table 3 Response to treatment by treatment response score subgroups in the three clinical trials

From: Defining responders to therapies by a statistical modeling approach applied to randomized clinical trial data

Trial

Score group

Number of patients (%)

Cumulative probability of 2-year EDSS progression

Treatment effect

 

Total

Placebo

Laquinimod

Placebo

Laquinimod

HR (95% CI)

p*

ALLEGRO

N = 1101

NR

426 (38.7)

219 (51.4)

207 (48.6)

6.30

8.87

1.31 (0.77–2.25)

0.0007

R

675 (61.3)

336 (49.8)

339 (50.2)

10.74

4.03

0.38 (0.23–0.62)

BRAVO

N = 881

NR

367 (41.7)

181 (49.3)

186 (50.7)

7.09

8.81

1.24 (0.70–2.19)

0.006

R

514 (58.3)

268 (52.1)

246 (47.9)

9.12

3.65

0.40 (0.22–0.73)

CONCERTO

N = 1456

NR

1015 (69.7)

526 (51.8)

489 (48.2)

6.09

6.56

1.08 (0.74–1.58)

0.033

R

441 (30.3)

211 (47.8)

230 (52.2)

5.62

2.47

0.44 (0.21–0.94)

  1. Score group: NR non-responders (patients with a response score > − 0.31), R responders (patients with a response score ≤ − 0.31)
  2. EDSS Expanded Disability Status Scale, HR hazard ratio, CI confidence interval
  3. *p for treatment by score interaction