CGRP inhibitor quality of life outcomes in major preventative trials
Clinically significant change | Subjects | Dose | MIDAS | HIT-6 | MSQ | MPFID | ||||
−5(s71) | −2.5(s64),(s72) | R: 3.2, F: 7.5(s24) | 3–5(s63),(s73) | |||||||
Active | Placebo | Active | Placebo | Active | Placebo | Active | Placebo | |||
Eptinezumab | ||||||||||
EM (phase II) NCT01772524(s64) | 174 | 1000 mg | – | – | −10.1 | −7.7 | P: −28.5 R: −21.4 F: −23.1 | P: −22.2 R: −18.0 F: −21.1 | – | – |
Erenumab | ||||||||||
EM (phase III) NCT02456740(s63) | 955 | 70 mg Q1/12 | – | – | – | – | – | – | A: −5.5 I: −4.2 | A: −3.3 I: 02.4 |
140 mg Q1/12 | – | – | – | – | – | – | A: −5.9 I: −4.8 | A: −3.3 I: 02.4 | ||
EM with 2–4 treatment failure (phase IIIb) NCT03096834(s21) | 246 | 140 mg Q1/12 | – | – | – | – | – | – | A: −3.4 I: −1.9 | A:+0.6 I:+1.6 |
CM with MOH (subgroup)(s24) | 274 | 70 mg Q1/12 | −22.0 | −3.6 | −5.2 | −2.9 | P: −11.6 R: −17.1 F: −17.1 | P: −7.7 R: −11.7 F: −8.2 | ||
140 mg Q1/12 | −16.1 | −3.6 | −5.4 | −2.9 | P: −10.5 R: −17.4 F: −15.9 | P: −7.7 R: −11.7 F: −8.2 | ||||
Fremanezumab | ||||||||||
EM (phase IIb) NCT02025556(s25) | 297 | 675 mg Q1/12 | −24.93 | −9.73 | ||||||
EM (phase III) NCT02629861(s26) | 875 | 225 mg Q1/12 | −19.0 | −12.5 | ||||||
675 mg Q3/12 | −18.0 | −12.5 | ||||||||
EM/CM ≥2 prev. treatment (phase IIIb) NCT03308968(s27) | 838 | 225 mg Q1/12 | −24.7 | −7.0 | −6.1 | −2.2 | −17.5 | −6.9 | ||
675 mg Q3/12 | −19.7 | −7.0 | −5.2 | −2.2 | −15.7 | −6.9 | ||||
CM (phase III) NCT02621931(s28) | 1130 | 225 mg Q1/12 | −6.8 | −4.5 | ||||||
675 mg Q3/12 | −6.4 | −4.5 | ||||||||
Galcanezumab | ||||||||||
EM (phase III) NCT02614196(s29) | 915 | 120 mg Q1/12 | −21.2 | −12.0 | – | – | R: −28.5 | R: −19.7 | – | – |
240 mg Q1/12 | −20.2 | −12.0 | – | – | R: −27 | R: −19.7 | – | – | ||
CM (phase III) NCT02614261(s30) | 1113 | 120 mg Q1/12 | −20.3 | −11.5 | – | – | P: −18.0 R: −21.8 F: −21.0 | P: −11.0 R: −16.8 F: −14.1 | – | – |
240 mg Q1/12 | −17 | −11.5 | – | – | P: −16.1 R: −23.1 F: −20.7 | P: −11.0 R: −16.8 F: −14.1 | – | – | ||
CM ≥1 treatment failures NCT02614261(s70) | 573 | 120 mg Q1/12 | – | – | – | – | R: −21.6 | R: −13.6 | – | – |
240 mg Q1/12 | – | – | – | – | R: −19.2 | R: −13.6 | – | – |
A, MPFID activities score; CM, chronic migraine; EM, episodic migraine; F, MSQ-functional score; I, MPFID physical impairment score; MPFID, Migraine Physical Function Impact Diary; MSQ, Migraine Specific Quality-of-life; P, MSQ-preventative score; R, MSQ-restrictive score.