Table 5 Primary and secondary measured efficacy outcomes in studies included and subgroups in each study, comparatively to those obtained with placebo

Ashina et al. NCT 02,066,415 [67]

Differences in LSM

 70 mg^{a, d}: − 2.7 (− 4.2; − 1.2)

 140 mg^{a, d}: −4.3 (− 5.8; − 2.8)

 (p < 0.001)

Proportion

 70 mg: 35.6%

 140 mg: 41.3%

OR vs placebo

 70 mg: 3.5 (1.8; 6.6)

 140 mg: 4.2 (2.2; 7.9)

 (p < 0.001)

Differences in LSM

 70 mg: − 2.8 (− 3.9; − 1.7)

 140 mg: − 4.1 (− 5.3; − 3.0)

 (p < 0.001)

No data

Ferrari et al. FOCUS (NCT03308968) [68]

Differences in LSM

 Quarterly^b: − 3.2 (− 4.2; − 2.2)

 Monthly^c: − 3.8 (− 4.8; − 2.8)

 (p < 0.001)

Proportion

 Quarterly 34%

 Monthly 34%

OR vs placebo

 Quarterly: 5.8 (3.6; 9.6)

 Monthly: 5.8 (3.6; 9.5)

 (p < 0.001)

Differences in LSM

 Quarterly: − 3.1 (− 3.8; − 2.4)

 Monthly: − 3.4 (− 4.0; − 2.7)

 (p < 0.0001)

Difference in LSM

 Quarterly: 8.8 (5.7; 11.9)

 Monthly: 10.6 (7.5; 13.7)

 (p < 0.0001; after 4 weeks)

Ruff et al. REGAIN (NCT02614261) [69]

Differences in LSM

 120 mg^{a, e}: − 4.35 (− 4.52; − 4.16) (p < 0.001)

 240 mg^{a, e}: − 1.77 (− 1.91; − 1.61) (p < 0.01)

Proportion

 120 mg 29.6%

 240 mg 18.7%

OR vs placebo

 120 mg: 4.05 (2.25; 7.31) (p < 0.001)

 240 mg: 2.22 (1.26; 3.92) (p < 0.01)

Differences in LSM

 120 mg: − 4.46 (− 4.64; − 4.28)

 240 mg: − 2.06 (− 2.20; − 1.90)

 (p < 0.001)

Differences in LSM

 120 mg: 8.45 (7.68; 9.24)

 240 mg: 8.57 (7.95; 9.19)

 (p < 0.01)

Mulleners et al. CONQUER (NCT03559257) [70]

Differences in LSM

 120 mg^{a, e}: − 3.7 (− 5.2; − 2.2) (p < 0.0001)

Proportion

 120 mg 32%

OR vs placebo

 120 mg: 4.8 (2.4; 9.6)

 (p < 0.0001)

Differences in LSM

 120 mg: − 3.9 (− 5.3; − 2.4)

 (p < 0.0001)

Differences in LSM

 120 mg: 13.9 (8.9; 18.9) (p < 0.0001)