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Dr. Richard Shek-Kwan Chang, 11 Oct 2018
A 38-year-old right-handed man had had epilepsy since 2 months of age. There was no relevant family history. Perinatal history was unremarkable. No other risk factors such as central nervous system infection or cerebral trauma were identified. Developmental history did not show major delay. His epilepsy was uncontrolled despite trying valproate, carbamazepine, clobazam, levetiracetam, oxcarbamazepine and perampanel. 

Fremanezumab: Sustained benefits across the board for refractory migraine

Pearl Toh
03 Jul 2020

After treatment with fremanezumab, a difficult-to-treat patient population with treatment-resistant episodic or chronic migraine saw sustained benefits across a broad range of measures, according to multiple analyses of the FOCUS study released during the AHS 2020 Virtual Meeting.

Improvements seen included reductions in migraine frequency, symptoms, and headache-related disability, as well as better quality of life during the open-label treatment phase.

The phase IIIb FOCUS study comprised two phases: a double-blind phase and an open-label extension phase, both lasting for 12 weeks. During the double-blind phase, patients with episodic or chronic migraine who failed two to four classes of prior migraine preventive therapies were randomized 1:1:1 to receive subcutaneous fremanezumab 675 mg quarterly, 225 mg monthly*, or matching placebo monthly. This was followed by the open-label phase whereby all patients received fremanezumab 225 mg monthly for 3 months. A total of 772 patients who completed the open-label extension phase were included in the analyses.

Migraine frequency, symptoms

At the end of the open-label phase, all patients continued to have fewer migraine episodes from baseline, with slightly more patients who previously received fremanezumab in the double-blind phase achieving ≥50 percent reduction in monthly average migraine days compared with those originally on placebo (45 percent and 46 percent vs 38 percent for fremanezumab quarterly and monthly vs placebo, respectively). [AHS 2020, 1st Jul session]

The proportions of patients achieving ≥75 percent reduction in migraine days were similar among the three groups (15 percent and 20 percent vs 16 percent).

“[The responses were] clinically meaningful … regardless of whether patients had received fremanezumab or placebo in the double-blind period,” observed the researchers.

In terms of migraine-related symptoms, more patients who received fremanezumab in the double-blind period saw greater reductions in nausea or vomiting during the open-label phase compared with those initially assigned to placebo (change from baseline in monthly average days, -3.1 and -3.0 vs -2.3, respectively).  

Other related symptoms such as photophobia and phonophobia were also less frequent with initial assignment to fremanezumab than placebo in the double-blind period (change from baseline in monthly average days, -3.4 and -4.0 vs -3.2, respectively).

For headache-related disability, substantial improvements were seen in all patients during the open-label phase regardless of their initial treatment in the double-blind period. Score reductions in Migraine Disability Assessment (MIDAS) were generally comparable across groups (-29.9 and -33.9 vs -27.3, respectively). When assessed using the Headache Impact Test (HIT-6), improvements were slightly greater in patients initially receiving fremanezumab vs placebo (mean, -8.4 and -8.3 vs -7.6, respectively).

Quality of life measures

There were also sustained improvements in quality of life with fremanezumab throughout the open-label period, as measured on the MSQoL**.

Health status, assessed using the EQ-5D-5L***, also improved at the end of the open-label phase, regardless of the initial treatment assigned during the double-blind period (mean change from baseline, 8.0 and 7.3 vs 6.6, respectively).

“Open-label administration of fremanezumab maintained improvements in health-related quality of life, as measured by both disease-specific and general quality of life questionnaires,” the researchers pointed out.

 

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Most Read Articles
Dr. Richard Shek-Kwan Chang, 11 Oct 2018
A 38-year-old right-handed man had had epilepsy since 2 months of age. There was no relevant family history. Perinatal history was unremarkable. No other risk factors such as central nervous system infection or cerebral trauma were identified. Developmental history did not show major delay. His epilepsy was uncontrolled despite trying valproate, carbamazepine, clobazam, levetiracetam, oxcarbamazepine and perampanel.