| Abstract | CILJ ISTRAŽIVANJA: Cilj ovog istraživanja bio je dobiti podatke o stopi ostanka na biološkoj terapiji u bolesnika s reumatoidnim artritisom liječenih u dnevnoj bolnici Zavoda za kliničku imunologiju i reumatologiju u sklopu Kliničkog bolničkog centra (KBC) Split, usporediti učinkovitost i tolerabilnost pojedinih bioloških lijekova u liječenju ove bolesti.
MATERIJAL I METODE: U ovom presječnom istraživanju uključeno je 86 pacijenata oboljelih od RA i liječenih u KBC-u Split. Istraživanje je obuhvatilo razdoblje od svibnja 2006. do kraja 2015. godine. Podaci su prikupljeni pomoću arhive povijesti bolesti. Kriteriji uključenja su bili Eular i ACR kriteriji iz 2010. godine te kriteriji prema općeprihvaćenim upitnicima za RA kao što su HAQ - Health Assesment Questionaire i DAS28 - Disease Activity Score.
REZULTATI: Omjer žena i muškaraca je 2,74:1. Adalimumab je najčešće korišteni lijek (31%), slijedi ga etanercept (27%), a rituksimab je najrjeđe korišten (7%). Ne postoji statistički značajna razlika u stopi ostanka na biološkoj terapiji s obzirom na korištenu terapiju (p=0,166). Lijek s najvećom prosječnom stopom ostanka u liječenju bolesnika s RA je rituksimab (41±34 mjeseci), potom etanercept (29±23 mjeseci) i adalimumab (24±25 mjeseci), a lijek ustekinumab nisu koristili. Lijek s najvećim postotkom neuspješnosti liječenja je infliksimab (71,43%), dok je rituksimab lijek koji ni u jednom slučaju nije prekinut kao terapija. Rituksimab ima značajno manju stopu neuspješnosti od etanercepta (p=0,0012), adalimumaba (p=0,0015), infliksimaba (p=0,000) i golimumaba (p=0,012), dok u odnosu na tocilizumab nema značajne razlike (p=0,085). Tocilizumab ima značajno manju stopu neuspjeha terapije od etanercepta (p=0,049), infliksimaba (p=0,000) i golimumaba (p=0,016), dok od već navedenog rituksimaba i adalimumaba (p=0,065) nema značajne razlike. U 32 pacijenta od njih 86 (37%) došlo je do prekida terapije prvim biološkim lijekom. Tako je od ukupno 133 primijenjena tretmana biološke terapije u navedenom razdoblju njih 47 (35,3%) bilo primijenjeno kao drugi, treći ili sljedeći biološki lijek po redu. S obzirom na stopu ostanka na biološkoj terapiji nema statistički značajne razlike u trajanju terapije između reumatoidnog artritisa i spondiloartropatija (p=0,927).
ZAKLJUČCI: Ne postoji značajna razlika u stopi ostanka na biološkoj terapiji s obzirom na korištenu terapiju. Lijek s najvećom stopom neuspješnosti liječenja je infliksimab, dok rituksimab i tocilizumab imaju najnižu stopu prekida biološke terapije. Najčešće korišteni lijekovi u liječenju RA su adalimumab i etanercept, a rituksimab je najrjeđe korišten. S obzirom na prosječnu stopu ostanka na biološkoj terapiji nema značajne razlike u trajanju terapije između reumatoidnog artritisa i spondiloartropatija. |
| Abstract (english) | OBJECTIVES: The aim of this study was to assess the retention rate of biological therapy in patients with rheumatoid arthritis (RA) treated in the Daily Hospital Division of Rheumatology and Clinical Immunology in Split and to compare the effectiveness and tolerability of biological drugs in the treatment of this disease.
METHODS: In this cross-sectional study 86 patients with RA were included and treated in the Clinical Hospital Centre Split. The study covered the period from May 2006 to the end of 2015. Data were collected using the medical history archives. Inclusion criteria were 2010 EULAR/ACR criteria and the criteria under generally accepted questionnaires for RA such as HAQ - Health Assessment Questionnaire and DAS28 - Disease Activity Score.
RESULTS: The sex ratio was 2.74: 1. Adalimumab was the most commonly used drug (31%), followed by etanercept (27%), and rituximab was the least used (7%). There was no statistically significant difference in the retention rate of the biological therapy considering the therapy used (p = 0.166). The drug with the highest mean retention rate in the treatment of RA patients was rituximab (41±34 months), then etanercept (29±23 months) and adalimumab (24±25 months), while drug ustekinumab was not used. The drug with the highest percentage of discontinuation was infliximab (71.43%), while rituximab had no discontinuations. Rituximab had a significantly lower discontinuation rate than etanercept (p = 0.0012), adalimumab (p = 0.0015), infliximab (p = 0.000) and golimumab (p = 0.012), while in relation to tocilizumab there was no significant difference (p = 0.085). Tocilizumab had a significantly lower discontinuation rate than etanercept (p = 0.049), infliximab (p = 0.000) and golimumab (p = 0.016), while from the foregoing rituximab and adalimumab (p = 0.065) there was no significant difference. In 32 patients out of 86 (37%), there had been an interruption of the first biological therapy. Out of 133 different biological treatments applied in the mentioned period, 47 of them (35.3%) were applied as second, third or other following drug in order. Considering the mean retention rate of biological therapy between rheumatoid arthritis and spondyloarthropaties, there was no statistically significant difference (p = 0.927).
CONCLUSIONS: There was no significant difference in the retention rate of the biological therapy considering the therapy used. The drug with the highest discontinuation rate was infliximab, while rituximab and tocilizumab had the lowest discontinuation rates of the biological therapy. The most commonly used drugs in the treatment of RA were adalimumab and etanercept, while rituximab was the rarest one. Considering the mean retention rate of biological therapy between rheumatoid arthritis and spondyloarthropaties, there was no significant difference. |
