Real world evidence in adults
Ailani et al., Frontiers in Pain Research, 2022
The Nerivio app includes a secured, personal migraine diary, which patients can use to record their symptoms before the treatment and 2 hours post-treatment, as well as additional symptoms and medication intake. Real-world data on Nerivio treatments were collected via the app from patients across the United States who used Nerivio between October 1st, 2019, and May 24th, 2021. Analyses were performed to examine the effectiveness and safety of Nerivio treatments, and prevalence of medications use following treatment.
Effectiveness analyses were conducted on data from 2,514 users who performed at least two treatments with voluntary reports of pain level before and after the treatment, and focused on consistency of response to treatment across multiple attacks. Reports of adverse events are analyzed for all 12,151 users, who performed a total of over 100,000 treatments.
Results:
- Treatment effectivity: 66% of the users achieved pain relief in at least half of their treatments, 23% achieved pain freedom in at least half of their treatments, 61% reported improvement in functional ability, and 30% experienced a return to normal function.
- Use of medications: In 67% of the treatments, users did not take any additional medications within two hours from the beginning of the treatment. In 13% of the treatments an over-the-counter medication was used, and only in 21% of the treatments a prescription medication was used (11% with triptans, 9% with other prescription medications).
- Adverse events: Out of the 12,151 users, only 59 patients (i.e. half of a percent, 0.48%) reported having adverse events. Of these, 56 users reported mild adverse events, and only 3 (0.03%) reported moderate ones. No patients reported any severe adverse events.
Conclusion: Large-scale real-world data confirms that Nerivio is safe and efficacious for the acute treatment of migraine.
Source: Ailani J, Rabany L, Tamir S, Ironi A, Starling A. Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. Front. Pain Res. 2022; 2:753736. doi: 10.3389/fpain.2021.753736