Oral Migraine Preventives: Real-World Study Results

A real-world observational study comparing the effectiveness of galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, to traditional oral migraine preventive medications (TOMPs) found that galcanezumab induced a higher proportion of patients achieving a meaningful reduction in migraine headache days. The study, known as TRIUMPH [Europe], enrolled 717 patients across Germany, Italy, Spain, and the UK between June 2020 and February 2023.

At three months, 63.1% of patients receiving galcanezumab experienced a ≥ 50% reduction in monthly headache days (MHDs) for episodic migraine, compared to 34.9% of those taking TOMPs. For patients with chronic migraine, 65.0% in the galcanezumab group achieved a ≥ 30% reduction in MHDs, versus 42.6% in the TOMP group. These results were published in the journal Headache.

Study Details and Patient Characteristics

The TRIUMPH [Europe] study was prospective and observational, meaning researchers followed patients over time and collected data without actively intervening. Participants were either initiating or switching to galcanezumab or TOMPs. The primary endpoint was the percentage of patients achieving the specified reduction in MHDs, tailored to whether they had episodic or chronic migraine.

The study included a total of 717 patients, with 46.0% in the galcanezumab group and 40.9% in the TOMP group. The majority of patients in both groups were women (85.8% and 85.3%, respectively), with a mean age of 44.4 years in the galcanezumab group and 36.8 years in the TOMP group. Chronic migraine was more prevalent in the galcanezumab group (60.9%) compared to the TOMP group (32.4%).

At baseline, patients in the galcanezumab group reported a mean of 14.8 MHDs (with a standard deviation of 7.2), while those in the TOMP group reported 10.3 MHDs (with a standard deviation of 5.2). After three months, the mean MHDs decreased to 7.7 (SD 7.4) for galcanezumab and 6.8 (SD 5.5) for TOMP.

Changes in Acute Medication Use

In addition to the reduction in MHDs, the study also assessed changes in the use of acute migraine medication. Patients receiving galcanezumab reported a decrease of 6.6 days in MHDs with acute medication use, compared to a decrease of 2.9 days in the TOMP group.

Limitations and Context

Researchers noted that the TRIUMPH [Europe] results are descriptive in nature, meaning no formal hypothesis testing was conducted to compare the treatment groups. This means the observed differences should be interpreted with caution. The study is ongoing, and further analysis may provide additional insights.

Galcanezumab has previously demonstrated efficacy in migraine prevention in clinical trials and is included in clinical guidelines. However, real-world data on its effectiveness have been limited until now. This study contributes to the growing body of evidence regarding the use of galcanezumab and other migraine preventive medications in clinical practice.

The TRIUMPH study (preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems) is an international, prospective observational cohort study comparing the effectiveness of galcanezumab with other preventives.