VAGAL NERVE STIMULATION IN THE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS – RESULTS THROUGH DAY 84 OBTAINED AT THE CROATIAN CENTER OF AN INTERNATIONAL PILOT STUDY

Električna stimulacija vagusa pokazala se učinkovitom u različitim upalnim stanjima na životinjskim modelima. Cilj je bio prikazati učinak neurostimulacije vagalnog živca na kliničke i laboratorijske pokazatelje u dva bolesnika s aktivnim reumatoidnim artritisom (RA) i nedostatnim odgovorom na metotreksat. Ispitanici i metode. Istraživanje je provedeno u sklopu međunarodne pilot-studije. Bolesnicima je ugrađen sustav Cyberonics za električnu stimulaciju vagusa. Nakon prve unutarbolničke stimulacije bolesnici su započeli sa stimuliranjem kod kuće do dana 42. kada je uređaj deaktiviran. Na dan 56. stimulacije su nastavljene. Evaluirani su ovi parametri: broj bolnih zglobova, broj otečenih zglobova, liječnikova (PGA) i bolesnikova (PtGA) globalna ocjena, jačina boli, aktivnost bolesti (DAS28), funkcionalna sposobnost (HAQ), serumska vrijednost CRP-a, kao i odgovor na terapiju prema EULAR-ovim kriterijima. Rezultati. U oba je bolesnika od probirne vizite do dana 42. nastupilo poboljšanje u vrijednostima DAS28 (7,00 i 6,22 prema 4,03 i 2,13), PGA (70 i 53 prema 27 i 16), PtGA (48 i 43 prema 15 i 14), broja bolnih zglobova (26 i 28 prema 4 i 0) i broja otečenih zglobova (24 i 14 prema 8 i 2), jačine boli (72 i 87 prema 21 i 7), vrijednosti HAQ-a (2,25 i 2,25 prema 1,5 i 1,375) te razine CRP-a (23,8 i 5,58 prema 13 i 4,61). Nakon isključenja uređaja došlo je do pogoršanja DAS28 i VAS-a boli u oba pacijenta. Zaključak. Vagalna neuralna stimulacija u liječenju bolesnika s aktivnim RA i nedostatnim odgovorom na tera piju metotreksatom učinkovita je u smanjenju kliničkih simptoma i pokazatelja upale. Naši su rezultati u skladu s rezultatima dobivenim i u drugim centrima. Potrebna su istraživanja na većem broju ispitanika da bi se bolje ocijenio učinak ovoga novog pristupa liječenju bolesnika s reumatoidnim artritisom.Electrical stimulation of the vagus has proven eff ective in various infl ammatory conditions in animal models. Th e aim of this study is to show the eff ect of vagal nerve neurostimulation on clinical and laboratory parameters in two patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate. Patients and methods. Th e research was conducted as part of an international pilot study. Patients were implanted with the Cyberonics system for electrical stimulation of the vagus. Aft er an initial in-clinic stimulation, the patients performed the stimulations at home for 42 days, when the device was inactivated. On day 56 the stimulations were reinitiated. Th e following parameters were evaluated: tender and swollen joint count, physician’s (PGA) and patient’s (PtGA) global score, intensity of pain, disease activity (DAS28), functional ability (HAQ), serum CRP level, and EULAR response. Results. In the period from the screening visit to the day 42 visit, both patients experienced an improvement of DAS28 (7.00 and 6.22 vs. 4.03 and 2.13), PGA (70 and 53 vs. 27 and 16), PtGA (48 and 43 vs. 15 and 14), tender joint count (26 and 28 vs. 4 and 0), swollen joint count (24 and 14 vs. 8 and 2), intensity of pain (72 and 87 vs 21 and 7), HAQ score (2.25 and 2.25 vs. 1.5 and 1.375), and CRP levels (23.8 and 5.58 vs. 13 and 4.61). Aft er the device deactivation, DAS28 and VAS pain worsened in both patients. Conclusion. Vagal neural stimulation in the treatment of patients with active RA and an inadequate response to methotrexate is eff ective in reducing clinical symptoms and parameters of infl ammation. Our results are in accordance with the results obtained in other centers. Research on a larger number of subjects is necessary for a better evaluation of the eff ect of this new approach to the treatment of patients with rheumatoid arthritis