Galcanezumab Demonstrates Efficacy and Safety in Treating Migraine
Safety, tolerability, efficacy, and side effects were observed to be better for galcanezumab than those associated with previous migraine preventatives.
Galcanezumab has been associated with high patient satisfaction, lower healthcare resource utilization for migraine, and reduced medication use for migraine, according to a study recently published in Patient Preference and Adherence. Safety, tolerability, efficacy, and side effects were observed to be better than those associated with previous migraine preventatives.
This open-label, phase 3 study included 270 participants with chronic (n=57) or episodic (n=213) migraine who were randomly assigned to galcanezumab 120 mg (n=135 with a 240-mg loading dose) or 240 mg (n=135). Participants were given 1 year of once-monthly, subcutaneously administered treatment. Data were collected on healthcare resource utilization for the past half year before study initiation, as well as for the periods between study visits.
To gauge satisfaction among the sample, the self-rated Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scale was used. A mixed model with repeated measures was used to compare the number of mean monthly headache days at each visit with baseline, and participants self-reported the use of any severe headache medication.
Most participants (69%) reported positive feedback in terms of satisfaction, lower side effects, and preference compared with previous treatments at months 1, 6, and 12. Galcanezumab 120 mg use was associated with an average 5.6-day reduction in mean monthly headache days (5.1 days for episodic, 7.2 days for chronic), whereas 240 mg was associated with a 6.5-day reduction (6.1 days for episodic, 8.2 days for chronic), with an overall decrease of 5.1 for both (P <.001).
Healthcare resource utilization was also lower in terms of visits to professionals (173.4 to 59.6 per 100 person-years), hospitalizations (3.7 to 0.4), and visits to the emergency department (20.2 to 4.7). The 2 doses showed no statistically significant difference in terms of reduced healthcare resource utilization.
Limitations to this study included a small sample size that may have resulted in wide confidence intervals, as well as a small number of trial countries and a resultant lack of generalizability.
The study researchers concluded that "patient satisfaction and preference measures were high for galcanezumab, and side effects were identified as being lower versus previously used preventives. The efficacy, dosing regimen, and safety/tolerability profile of galcanezumab have the potential to improve health outcomes among patients with migraine who are in need of a preventive treatment."
This study received funding from Eli Lilly and Company, and all authors report associations with either Eli Lilly and Company or other pharmaceutical companies. For a full list of author disclosures, visit the reference.
Ford JH, Foster SA, Stauffer VL, Ruff DD, Aurora SK, Versijpt J. Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine. Patient Prefer Adherence. 2018; 12:2413-2424. doi: 10.2147/PPA.S182563