Fremanezumab Found to Reduce Number of Migraine Days in Patients With Chronic Migraine and Comorbid Depression

Woman with hands on her head
Close-up shot of a woman suffering from a headache and rubbing her temples at home
A pooled analysis evaluated reductions in migraine and headache days among patients with chronic migraine and comorbid depression in 2 placebo-controlled, phase 3 trials of fremanezumab.
(HealthDay News) — A day after his inauguration, President Joe Biden plans to unveil a new, far-reaching pandemic response plan. He will also issue executive orders that aim to ramp up the production and distribution of COVID-19 tests and vaccines, make schools and travel safer, and help states fight the spread of COVID-19.

Biden has repeatedly promised to get 100 million COVID-19 shots into the arms of the American people by his 100th day in office; he has already directed the Federal Emergency Management Agency to begin constructing federally supported community vaccination centers, with the goal of having 100 centers in operation within the next month.

On Wednesday, Biden signed three executive orders relating to the COVID-19 pandemic shortly after taking office, The New York Times reported. They require mask wearing and social distancing on federal property and under other limited circumstances; halting the Trump administration’s withdrawal from the World Health Organization; and recreating a White House unit on global health security and biodefense that was disbanded a few years ago, the newspaper said.

For travel, the president plans to sign an executive order requiring masks to be worn in airports and international travelers to show proof of a negative COVID-19 test before boarding planes to the United States, The Times said.

The New York Times Article

Treatment with fremanezumab, the fully humanized IgG2Δa monoclonal antibody that selectively targets calcitonin gene-related peptide, significantly reduced the number of headache or migraine days experienced before therapy. These findings, from a pooled analysis of phase 3 trials, were presented at Psych Congress 2020, held virtually from September 10 to 13, 2020.

Patients (N=368) with chronic migraine, as defined by ³15 days per month of moderate to severe headache, and concurrent depression, as defined by a Patient Health Questionnaire (PHQ-9) score ³10, were included in the international, multicenter, randomized, double-blind, placebo-controlled studies. Participants. were randomly assigned in a 1:1:1 ratio to receive monthly (n=130; fremanezumab 675 mg the first month followed by fremanezumab 225 mg for 2 months), quarterly (n=131; fremanezumab 675 mg the first month followed by placebo for 2 months, or placebo (n=107) injections.

A difference among treatment and placebo groups was observed after the first month of treatment. The mean decrease in the number of days with migraine among participants in the monthly treatment group was 4.3 (P <.001) and in the quarterly group was 4.6 (P <.0001); these decreases were statistically significant compared with the decrease reported by the placebo group (1.5 days).

The decrease in the number of days with migraine remained significant over the duration of the study. The mean decrease reported by placebo recipients was 1.9 (standard deviation [SD], 0.63) days compared with participants who received monthly (4.9 days; SD, 0.59; P <.001) and quarterly (4.6 days; SD, 0.56; P <.001) injections.

Similarly, the average number of days with a moderate to severe headache decreased after a single treatment (placebo: 1.2 days vs monthly: 4.9 days; P <.0001 or quarterly: 5.0 days; P <.0001). Over the entire study duration, the placebo group reported an average of 1.7 (SD, 0.59) fewer days with headache compared with participants who received monthly (5.2 days; SD, 0.56; P <.02) or quarterly (4.6 days; SD, 0.53; P <.02) treatments.

A limitation of this study was that these data were from a subset of individuals from 2 separate studies. Although the studies were of similar design, some bias may have been introduced.

With these observations, the study authors concluded that after injection with fremanezumab, the number of migraine or headache days experienced by individuals with comorbid chronic migraine and depression were effectively reduced.

Disclosure: This study was sponsored by Teva Pharmaceuticals, which also employed 4 of the study authors.  Please refer to the original document for a full list of disclosures.

(HealthDay News) — For patients with symptomatic, radiographically confirmed osteolysis undergoing revision total hip arthroplasty surgery, a single dose of denosumab results in a reduction in osteoclast numbers, according to a study published online Jan. 11 in The Lancet Rheumatology.

Mohit M. Mahatma, from the University of Sheffield in the United Kingdom, and colleagues conducted a phase 2 randomized, proof-of-concept superiority trial involving patients aged 30 years or older and scheduled for revision total hip arthroplasty surgery for symptomatic, radiographically confirmed osteolysis. Participants were randomly assigned to either subcutaneous denosumab or placebo. The between-group difference in osteoclast number per millimeter of bone surface of biopsies taken from the osteolytic membrane-bone interface at surgery eight weeks later was assessed as the primary outcome.

Ten patients in the denosumab group and 12 in the placebo group were assessed for the primary outcome. The researchers found that compared with the placebo group, in the denosumab group, there were 83 percent fewer osteoclasts at the osteolysis membrane-bone interface (median, 0.05 versus 0.30 per mm). There were no deaths or treatment-related serious adverse events reported.

“The results of this proof-of-concept clinical trial indicate that denosumab is effective at reducing bone resorption activity within osteolytic lesion tissue and is well tolerated within the limitations of the single dose used here,” the authors write.

The study was funded by Amgen. Amgen provided denosumab and placebo free of charge.

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Buse DC, Cohen JM, Ning X, Yang R, Ramirez Campos V, Lipton RB. Fremanezumab for the prevention of chronic migraine in patients with comorbid depression: a pooled analysis of phase 3 studies. Presented at: Psych Congress 2020 Virtual Experience; September 10-13, 2020. Poster 155.

This article originally appeared on Psychiatry Advisor