Background:Despite the clinical benefits of current pharmacological treatments for rheumatoid arthritis (RA), there remains an unmet need for alternative treatment approaches. Initial results of a 12-week proof-of-concept study of non-invasive, vagus nerve stimulation (VNS) of the auricular branch of the vagus nerve from a wearable device to treat RA showed the device to be well-tolerated with significant reductions in the DAS28-CRP and RA disease severity1.Objectives:This analysis presents data from the 9-month extension of the original proof-of-concept study.Methods:Following the completion of the 12-week proof-of-concept study, responding patients (defined as achieving a reduction in DAS28-CRP of ≥1.2 from baseline and/or achievement of ACR20) were given the option to enroll in a 9-month extension study. Use of the wearable device continued daily for up to 30 minutes as in the first 12 weeks of the study. Alteration of baseline medication and addition of conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic DMARDs were allowed during the extension phase.Results:20/27 patients who completed the initial 12-week study met the enrollment criteria for the extension phase; 19 of those patients consented to participate. 4/19 patients (21%) discontinued the extension study due to lack of efficacy (1 patient after 1 month, 2 patients after 3 months, and 1 patient after 6 months in the extension); 15 patients completed the extension phase. 2/15 patients (13%) added biologic therapy to their treatment regimen. Mean DAS28-CRP reduction from baseline to the end of the extension (12 months total) in all patients completing the extension was 2.23 (95% CI: -1.60, -2.86). For patients who did and did not add biologic therapy, mean DAS28-CRP reduction was 2.98 and 2.11, respectively. Individual DAS28-CRP reductions are shown in the figure 1. Mean HAQ-DI reduction from baseline to the end of the extension in all patients was 0.70. 2 non-device related adverse events were reported in the study extension: one related to cornea transplant and one related to dysesthesia. No serious adverse events were reported during the study extension phase.Conclusion:Benefits from the use of the wearable device were maintained over longer periods of time from the initial 12-week proof-of-concept study, with few safety concerns as no additional side effects were observed.References:[1]Marsal S et al. Non-invasive Vagus Nerve Stimulation Improves Signs and Symptoms of Rheumatoid Arthritis: Results of a Pilot Study [in press]. The Lancet Rheumatol, 2021Disclosure of Interests:Sara Marsal Speakers bureau: BMS, Pfizer, UCB, Celgene, Roche, Sanofi, Consultant of: Pfizer, Abbvie, Roche, Celgene, Galapagos, MSD, UCB, BMS, Sanofi, Grant/research support from: Pfizer, Abbvie, Roche, Celgene, MSD, UCB, BMS, Novartis, Janssen, Sanofi, Héctor Corominas: None declared, Juan Jose de Agustin: None declared, Carolina Perez-Garcia: None declared, Maria Lopez Lasanta: None declared, Helena Borrell Paños: None declared, D Reina-Sanz: None declared, Raimón Sanmartí: None declared, J. Narváez: None declared, Clara Franco-Jarava: None declared, Charles Peterfy Speakers bureau: Novartis, Bristol Myers Squibb, Amgen, Consultant of: Multiple companies on behalf of Spire Sciences Inc., Jose Antonio Narvaez: None declared, Vivek Sharma Shareholder of: Nēsos Corp, Employee of: Nēsos Corp, Konstantinos Alataris Shareholder of: Nēsos Corp, Employee of: Nēsos Corp, Mark C. Genovese Shareholder of: Gilead Sciences, Nēsos Corp, Employee of: Gilead Sciences, Matthew Baker Shareholder of: Nēsos Corp, Consultant of: Nēsos Corp
Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis
