Sodelovanje in vztrajanje pacientov z multiplo sklerozo pri zdravljenju z zdravili v Sloveniji

Žnidaršič, Kristjan (author), Kos, Mitja (mentor)

Uvod: Sodelovanje in vztrajanje pri terapiji z imunomodulatornimi zdravili (IMZ) za multiplo sklerozo (MS) je bistvenega pomena pri optimiziranju koristi zdravljenja in kliničnih rezultatov za bolnike. Namen te raziskave je bil ovrednotiti sodelovanje in vztrajanje pri zdravljenju pacientov z MS v Sloveniji ter oceniti vpliv, ki bi ga lahko imeli izbrani dejavniki. Metode: Študija je vključevala bolnike, ki so začeli zdravljenje z IMZ v letih 2011–2014 in so imeli vsaj eno izdajo katerega koli zdravila na recept po 5-letnem opazovalnem obdobju. Iz analize smo izključili paciente, ki so prejeli izdajo natalizumaba. Analizo smo izvedli s programsko opremo AdhereR. Sodelovanje smo ocenili z algoritmom CMA5, z metodo deleža dni, pokritih z zdravilom (PDC), ter nato z metodo ANOVA preverili vplive različnih dejavnikov. Pri sodelovanju smo upoštevali tudi zamenjave IMZ ter paciente opazovali od njihove prve do zadnje izdaje v obdobju 5 let. Paciente smo smatrali kot sodelujoče, če so izkazovali PDC > 80 %. Vztrajanje smo opredelili kot odsotnost zamenjave prvega izdanega IMZ ali brez vrzeli (> 60 dni) med zdravljenjem. Analizo smo izvedli s pomočjo Kaplan-Meierjeve analize preživetja. Vpliv različnih dejavnikov na vztrajanje smo ocenili s testom log-rank. Rezultati: Pet let smo spremljali 316 pacientov s povprečno starostjo 43 let, od katerih je bilo 70,8 % žensk. Njihovo povprečno sodelovanje v obdobju petih let je bilo 82,9 %, pri čemer jih je bilo od 316 69,9 % sodelujočih. Dejavniki, kot so spol, starost in regija, niso imeli statistično značilnega vpliva na sodelovanje in vztrajanje. Po opazovalnem obdobju petih let je bilo vztrajnih še 18,6 % pacientov. Vztrajanje je bilo 33,1 % pri glatiramer acetatu ter 25,0 % pri interferonih beta (1a in 1b, subkutane ter intramusularne aplikacije), medtem ko je bilo nižje pri teriflunomidu (11,1 %), fingolimodu (3,5 %) ter dimetilfumaratu (0 %). Pri injekcijskih IMZ je bilo vztrajanje (31,2 %) bistveno višje, v primerjavi s peroralnimi oblikami (3,5 %). Kljub temu je pri izbiri posamezne terapije treba upoštevati tudi druge dejavnike, vključno z učinkovitostjo, varnostjo ter primernostjo za posameznega pacienta.

• Language: Slovenian
• Keywords: Multipla skleroza, AdhereR, sodelovanje pri zdravljenju, vztrajanje pri zdravljenju
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-141558
• Publication date in RUL: 01.10.2022

Secondary language

• Language: English
• Title: Medication adherence and persistance of patients with multiple sclerosis in Slovenia

Abstract

Introduction: Adherence and persistence to immunomodulatory therapies for multiple sclerosis (MS) plays an essential role in maximizing the treatment benefits and patient outcomes. The aim of this study was to evaluate medication adherence and persistence of patients with multiple sclerosis in Slovenia and assess the impact certain variables may have on them. Methods: The study included patients, who began their treatment with disease-modifying drugs (DMDs) in years 2011 - 2014 and had at least one prescription fill of any medication after an observational window of 5 years. Patients that received a natalizumab prescription were excluded from the analysis. The analysis was conducted using AdhereR software. Adherence was assessed using the algorithm CMA5, using the method of proportion of days covered (PDC), together with ANOVA to evaluate the impact of various factors. Whilst assessing adherence we included DMD switches and followed patients from the first to last dispensing within the 5-year period. Patients were considered adherent if they had PDC > 80%. Persistence was defined as no evidence of switching from the first prescribed immunomodulatory drug or no treatment gap > 60 days and analyzed using Kaplan-Meier analysis. The impact of various factors on persistence was evaluated using the log-rank test. Results: A total of 316 patients were followed for 5 years, with the average age of 43 years, of whom 70.8% were female. The average adherence in a 5-year period was 82,9 %, with 69,9 % of the 316 patients being adherent (PDC > 80%). Factors such as gender, age and region had no significant correlation with adherence and persistence. During the 5-year period it was found that persistence rate was 18,6 %. Persistence was 33,1 % with glatiramer acetate and 25,0 % with beta interferons (1a and 1b, subcutaneous and intramuscular applications), while persistence was lower with teriflunomide (11,1 %), fingolimod (31,2 %) and dimethyl fumarate (0%). The persistence with injectable DMDs (31,2 %) was significantly higher compared to oral DMDs (3,5 %). Nevertheless, when choosing individual therapy, it is necessary to consider other factors, including efficacy, safety, and patient suitability.

• Keywords: Multiple sclerosis, AdhereR, medication adherence, medication persistence