Takeaway
- Patients with episodic migraine who received subcutaneous fremanezumab needed acute headache and migraine-specific medication less often than those who received a placebo and reported lower incidences of nausea or vomiting, photophobia, and phonophobia.
Why this matters
- These findings were observed with both a monthly and quarterly dose regimen.
Study design
- The phase 3 (HALO) randomized, double-blind, placebo-controlled trial enrolled patients with episodic migraine.
- Patients received subcutaneous fremanezumab (225 mg monthly, n=290; 675 mg quarterly, n=291) or placebo (n=294) for 12 weeks.
- Funding: Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
Key results
- Treatment with fremanezumab (monthly and quarterly, respectively) vs placebo reduced:
- number of days of acute headache medication use (least-squares mean [LSM] change, −1.4 and −1.3; Pboth<.001); and
- migraine-specific acute headache medication use (LSM change, −2.2 and −2.2; Pboth<.001).
- Migraine-associated symptoms reduced with fremanezumab (monthly and quarterly, respectively) vs placebo:
- number of days with nausea/vomiting (difference: −0.7 [P<.001] and −0.5 [P=.031]);
- photophobia (difference: −0.9 [P<.001] and −0.8 [P=.002]);
- phonophobia (difference: −1.0 [P<.001] and −0.6 [P=.009]).
- Rates of severe adverse events (AEs), serious AEs, and AEs leading to discontinuation were similar across treatment groups (≤2%).
Limitations
- Prespecified exploratory analyses.
Coauthored with Chitra Ravi, MPharm
References
References