An Overview of New Biologics for Migraine Prophylaxis

Philip Harvey, PharmD/MBA Candidate 2020; Pooja Shah, PharmD/MBA Candidate 2020; Scott Shipley, PharmD, BCPS

Disclosures

US Pharmacist. 2020;45(1):21-24. 

In This Article

Clinical Trials

The efficacy of erenumab, fremanezumab, and galcanezumab for the treatment of migraine has been established in clinical trials.[6–8]

Erenumab

A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III trial assessed the safety and efficacy of the erenumab injection (70 mg and 140 mg) compared with placebo in 955 patients with episodic migraine. The study period was 6 months. From baseline to the final 3 months (months 4–6) of the double-blind treatment phase, the overall reduction in average migraine days per month was 3.2 days in the 70-mg erenumab group and 3.7 days in the 140-mg erenumab group, compared with 1.8 days in the placebo group (both doses vs. placebo, P <.001). A reduction of at least 50% in average migraine days per month from baseline to months 4 through 6 was achieved by 43.3% of patients in the 70-mg erenumab group and 50.0% of patients in the 140-mg erenumab group, compared with 26.6% in the placebo group (both doses vs. placebo, P <.001).[9]

A randomized, double-blind, placebo-controlled, multicenter, phase II study of erenumab in adults aged 18 to 65 years with chronic migraine evaluated 667 patients taking erenumab (70 mg or 140 mg) versus placebo. Both erenumab doses reduced monthly migraine days versus placebo (−6.6 days for both doses vs. –4.2 days for placebo; total difference of –2.5 for each dose; 95% CI, −3.5 to –1.4; P <.0001), leading to FDA approval for both dosing regimens.[10]

Fremanezumab

A randomized, double-blind, placebo-controlled, parallel-group study compared fremanezumab (225 mg monthly or 675 mg quarterly) with placebo in 875 patients with episodic migraine. Mean migraine days per month decreased from 8.9 days to 4.9 days in the 225-mg group; from 9.2 days to 5.3 days in the 675-mg group; and from 9.1 days to 6.5 days in the placebo group. This resulted in a difference of –1.5 days for 225-mg-monthly dosing versus placebo (95% CI, −2.01 to –0.93 days; P <.001) and –1.3 days for 675-mg-quarterly dosing versus placebo (95% CI, −1.79 to –0.72 days; P <.001).[11]

A randomized, double-blind, placebo-controlled, parallel-group trial compared fremanezumab quarterly and fremanezumab monthly versus placebo (1:1:1 ratio) in 1,130 patients with chronic migraine. The mean number of headache days per month was reduced by 4.3 ± 0.3 days in the fremanezumab-quarterly group, 4.6 ± 0.3 days in the fremanezumab-monthly group, and 2.5 ± 0.3 days in the placebo group (P <.001 for both comparisons). Significantly more patients receiving fremanezumab had a reduction of at least 50% in the average number of headache days per month (quarterly regimen, 38%; monthly regimen, 41%) compared with placebo patients (18%; P <.001 for both comparisons).[12] As a result, fremanezumab is approved in dosages of both 225 mg monthly and 675 mg quarterly.

Galcanezumab

A global, double-blind, randomized, placebo-controlled trial (EVOLVE-2) investigated the safety and efficacy of galcanezumab (120 mg and 240 mg) versus placebo in 858 patients with episodic migraine over a 6-month period. Treatment with galcanezumab significantly reduced monthly migraine headache days by 4.7 days (120 mg) and 4.6 days (240 mg), respectively, compared with placebo (2.8 days; P <.001 for both comparisons). Substantially more patients receiving galcanezumab had a reduction of more than 50% in mean headache days per month versus placebo (65% for galcanezumab vs. 42% for placebo; P <.001).[13,14]

REGAIN, a phase III, randomized, double-blind, placebo-controlled study of galcanezumab in 1,113 patients with chronic migraine, evaluated monthly SC injections of placebo, galcanezumab 120 mg (with a 240-mg loading dose), or galcanezumab 240 mg in a 2:1:1 ratio. Both galcanezumab groups demonstrated greater overall mean reductions in number of headache days per month compared with placebo (placebo –2.7, galcanezumab 120 mg –4.8, galcanezumab 240 mg –4.6; P <.001 for each dose vs. placebo).[15] The recommended dosage is 240 mg as an initial loading dose, followed by 120 mg monthly.

A randomized, double-blind, placebo-controlled study comparing galcanezumab and placebo in adult patients with cluster headache was conducted over 8 weeks. Galcanezumab reduced the number of weekly cluster headache attacks by an average of 8.7 versus 5.2 with placebo (P = .036 vs. placebo) over weeks 1 to 3.[16] As a result, in 2019, galcanezumab became the first drug to be approved by the FDA for treating episodic cluster headache (it was approved for preventive treatment of migraine in 2018).[17]

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