Real-World Evidence (RWE) Data Analysis of 1-Year Consecutive Use of Nerivio (NCT05760638)

Many migraine patients struggle with adherence as a result of intolerance of side effects, lack of efficacy, risk of chronification, and/or high cost. The current available first-line acute treatments do not provide a sustainable solution for many patients with migraine for several reasons (e.g they are not universally effective in managing headache and they can have intolerable adverse effects, they do not appropriate for all patients with migraine due to contraindications, they can lead to Chronification of migraine, and more)

Based on these factors, many patients struggle with adherence to pharmacological acute migraine treatments. Thus, there is a need for tolerable, safe, and effective treatments that can be used for long durations (years) to help individuals regain daily function and relief from pain.

Study objectives

This study aims to examine Nerivio long-term safety, efficacy, and usage. The hypothesis is that Nerivio provides a safe, efficacious, and stable treatment over 1 year of consecutive use.

Study primary endpoint

Device safety

The incidence of adverse events in general and by seriousness, severity and association to the device, as reported by the users. All adverse events that were reported by participants were analyzed including the following information: device-related AEs, description, severity and whether they were serious. and all other Nerivio patients.

Secondary efficacy endpoints

Utilization.

Consistency of monthly usage of Nerivio device was recorded during 12 calendar months. Consistent usage indicates both adherence and overall satisfaction.

Efficacy.

Consistent Headache Relief at 2 Hours Post-treatment: The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments.

Consistent Freedom From Headache at 2 Hours Post-treatment: The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments.

Consistent Functional Disability Relief at 2 Hours Post-treatment: The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.

Consistent Functional Disability disappearance at 2 Hours Post-treatment: The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.

Results

Four hundred and nine (n=409) Nerivio users were found to match the inclusion/exclusion criteria for the study. The average age of patients was 45.8±15.9 years (mean ± SD), and 84.6% were female, 13.7% male, and 1.7% undefined.

Nine AEs were reported during the study time period (2.20%, 9/409). Eight of these were device-related AEs (1.96%; 8/409). With respect to severity, two (0.49%) were defined as negligible, five (1.22%) were defined as mild, one was defined moderate (0.24%). No severe device-related AEs were reported. None of the reported AEs were considered serious (SAEs).

During the study period, users performed a total of 39,531 treatments, with a monthly average of 8.05 ± 1.15 (mean ± SD) treatments per patient. Table 1 1 shows the average month-to-month number of treatments for the users. A repeated-measures ANOVA determined that the month-to-month number of treatments conducted by patients did not differ significantly between 12 months of consecutive treatment [F(4.9, 1997.2) = 2.0, p = 0.075].

Table 1 – Month-to-month 1-year utilization. Monthly average number of REN treatments over 12 months over patients (n = 409). Error bars represent standard error (SE)

One-year average annual consistent efficacy in at least 50% of all treatments per patient was achieved by 74.1% (180/243) of patients for pain relief and by 26.0% (67/258) for freedom from pain. Figure 1 shows the average month-to-month consistent efficacy of pain relief and freedom from pain. Comparing consistent efficacy across 12 consecutive treatment months showed no significant difference in pain relief and pain freedom throughout the 12 months [F(11, 1069) = 0.55, p = 0.873 and F(11, 1295) = 0.69, p = 0.750, respectively].

Figure 1 – Month-to-month 1-year efficacy. Monthly percent responders for pain relief and freedom from pain

Average annual consistent efficacy in at least 50% of all treatments per patient was achieved by 70.2% (177/252) of patients for functional disability relief and by 33.7% (85/252) for functional disability freedom. Figure 2 shows the average month-to-month consistent efficacy of functional disability relief and functional disability freedom. Comparing consistent efficacy across 12 consecutive treatment months showed no significant difference in functional disability relief and functional disability freedom throughout the 12 months [F(11, 1202) = 0.860, p = 0.580 and F(11, 1202) = 0.77, p =0.672, respectively].

Figure 2 – Month-to-month 1-year efficacy. Monthly percent responders for functional disability pain relief and functional disability freedom

Moreover, regarding associated symptoms, average annual consistent efficacy in at least 50% of all treatments per patient was achieved by 43.2% (95/220) of patients for photophobia, by 52.7%% (107/203) of patients for phonophobia, by 70.8% (121/171) of patients for nausea/vomiting, and by 73.5% (180/245) of patients for at least one associated symptom.

Conclusions

This study demonstrated that long-term use of Nerivio (at least once per month for 12 months) was safe and effective. The device showed consistent efficacy, excellent safety profile, and consistent tolerability of REN over 12 months.