Clinical trials for AJOVY were designed to reflect real-world patient experience

AJOVY was evaluated in two phase 3 trials that enrolled patients with disabling migraine1

  • 1000+

    patients received AJOVY as a stand-alone preventive treatment1

    280+

    patients continued to receive their oral preventive treatment1

  •  

    Nearly 600 patients had discontinued prior preventive treatment2

     

    18%

    of women of childbearing age also took concomitant hormonal contraceptives2

  • There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY.1

HALO trial designs

AJOVY was evaluated in two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials1,2

Halo chronic
migraine (cm)

CM

defined as ≥15 headache days per month

Halo episodic
migraine (em)

EM

defined as <15 headache days per month

AJOVY quarterly treatment arm

Single dose of 675 mg at week 0 (three injections of 225 mg per 1.5 mL), followed at weeks 4 and 8 by placebo (one 1.5 mL injection at each visit)

AJOVY monthly treatment arm

CM: 675 mg dose at week 0 (three injections of 225 mg per 1.5 mL) and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)
EM: 225 mg dose at week 0 (one injection of 225 mg per 1.5 mL and two 1.5 mL injections of placebo), and 225 mg at weeks 4 and 8 (one injection of 225 mg per 1.5 mL at each visit)

Placebo

Three 1.5 mL injections at week 0 and one 1.5 mL injection at weeks 4 and 8
Baseline patient demographics2

Chronic Migraine

AJOVY Quarterly (n=376) AJOVY Monthly (n=379) Placebo (n=375)
Age (y), mean (SD) 42.0 (12.4) 40.6 (12) 41.4 (12)
Female, n (%) 331 (88) 330 (87) 330 (88)
Concomitant preventive medication use, n (%) 77 (20) 85 (22) 77 (21)
Concomitant acute headache medication use, n (%) 359 (95) 360 (95) 358 (95)
Discontinued prior preventive treatment, n (%) 130 (35) 141 (37) 136 (36)

Episodic Migraine

AJOVY Quarterly (n=291) AJOVY Monthly (n=290) Placebo (n=294)
Age (y), mean (SD) 41.1 (11.4) 42.9 (12.7) 41.3 (12)
Female, n (%) 251 (86) 244 (84) 247 (84)
Concomitant preventive medication use, n (%) 58 (20) 62 (21) 62 (21)
Concomitant acute headache medication use, n (%) 281 (97) 279 (96) 280 (95)
Discontinued prior preventive treatment, n (%) 58 (20) 65 (22) 63 (21)
CM primary endpoints1-3:
  • Mean change from baseline in the monthly average number of headache days* of ≥moderate severity during the 12-week period with (1) quarterly and (2) monthly dosing
CM secondary endpoints1-3:
  • Mean change from baseline in the monthly average number of migraine daysduring the 12-week period with (3) quarterly and (4) monthly dosing
  • Proportion of patients reaching ≥50% reduction in monthly average number of headache days of ≥moderate severity during the 12-week period with (5) quarterly and (6) monthly dosing
  • Mean change from baseline in the monthly average number of days of acute headache medication use during the 12-week period with (7) quarterly and (8) monthly dosing
  • Mean change from baseline in the monthly average number of headache days of ≥moderate severity during the 4-week period after the first dose (9)
  • Mean change from baseline in the monthly average number of headache days of ≥moderate severity during the 12-week period in patients not receiving concomitant preventive migraine medications with (10) quarterly and (11) monthly dosing
  • Mean change from baseline in the Headache Impact Test (HIT-6) score at 4 weeks after administration of the last dose with (12) quarterly and (13) monthly dosing
EM primary endpoints1.2.4:
  • Mean change from baseline in the monthly average number of migraine days during the 12-week period with (1) quarterly and (2) monthly dosing
EM secondary endpoints1.2.4:
  • Proportion of patients reaching ≥50% reduction in monthly average number of migraine days during the 12-week period with (3) quarterly and (4) monthly dosing
  • Mean change from baseline in the monthly average number of days of acute headache medication use during the 12-week period with (5) quarterly and (6) monthly dosing
  • Mean change from baseline in the number of migraine days during the 4-week period after the first dose for (7) quarterly and (8) monthly dosing
  • Mean change from baseline in the monthly average number of migraine days during the 12-week period in patients not receiving concomitant preventive migraine medications with (9) quarterly and (10) monthly dosing
  • Mean change from baseline in the Migraine Disability Assessment (MIDAS) questionnaire score at 4 weeks after administration of the last dose with (11) quarterly and (12) monthly dosing
Patients with chronic and episodic migraine experienced statistically significant improvements across all 25 primary and secondary endpoints studied1.3.4

 

*Headache days: a calendar day in which headache pain lasted at least 4 consecutive hours and had a peak severity of at least moderate level, or a day in which acute migraine-specific medication (triptans or ergots) was used to treat a headache of any severity or duration.3 Migraine days: a calendar day in which headache pain lasted at least 2 consecutive hours and met criteria for migraine (with or without aura) or probable migraine (subtype in which only one migraine criterion is absent), or a day in which acute migraine-specific medication (triptans or ergots) was used to treat a headache of any duration.3

 

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Flexibility to help you meet your patients' needs1

Dosing options for AJOVY