Učinkovitost liječenja biološkim lijekovima u reumatoidnom artritisu na postizanje remisije i niske aktivnosti bolesti

master's thesis

• Title (english): Effect of biological drug treatment in rheumatoid arthritis on achievement of remission and low disease activity
• Author: Kristina Hutinec
• Mentor: Nadica Laktašić Žerjavić (mentor)
• Committee member: Porin Perić (predsjednik povjerenstva)
• Committee member: Jasenka Markeljević (član povjerenstva)
• Committee member: Nadica Laktašić Žerjavić (član povjerenstva)
• Granter: University of Zagreb; School of Medicine; (Department of Physical Medicine and General Rehabilitation); Zagreb
• Defense date and country: 2019-07-12, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Clinical Medical Sciences; Physical Medicine and Rehabilitation

Abstract

Reumatoidni artritis (RA) je kronična sustavna autoimunosna bolest nepoznata uzroka koja primarno zahvaća zglobove, ali može zahvatiti i druge organske sustave. Karakteristično obilježje bolesti je perzistirajući simetrični sinovitis koji najčešće zahvaća periferne zglobove ekstremiteta. Standardno liječenje sustavnog RA podrazumijeva primjenu različitih skupina lijekova – analgetici, NSAR, glukokortikoidi (GK) i DMARDs. Prema definiciji HALMED-a biološki lijekovi su lijekovi čija se djelatna tvar proizvodi ili izlučuje iz biološkog izvora. Odobreni i najčešće korišteni biološki i ciljani sintetski lijekovi za liječenje RA u Republici Hrvatskoj su inhibitori TNF-α, inhibitori IL-6, inhibitori B-limfocita te JAK inhibitori.
Osnovni cilj ovog istraživanja bio je utvrditi udio bolesnika koji su preživjeli 12 mjeseci na prvom biološkom lijeku te utvrditi njihov ishod bolesti. Ostali ciljevi istraživanja bili su utvrditi učestalost i razloge prekida biološke terapije prvim biološkim lijekom, utvrditi učestalost nuspojava te usporediti dvije skupine lijekova (TNF-α inhibitori i lijekovi drugog mehanizma djelovanja).
U istraživanje je bilo uključeno 49 bolesnika prosječne starosti 49,63 (± 12,12) godina, s prosječnim trajanjem bolesti prije početka biološke terapije od 11,31 (± 6,55) godina. U skupini analiziranih, njih 34 (69,39%) je biološku terapiju započelo lijekovima iz skupine inhibitora TNF-α, a 15 (30,61%) lijekovima drugog mehanizma djelovanja (inhibitori IL-6, inhibitori B – limfocita i JAK inhibitori). Pratio se tijek terapije na prvom biološkom lijeku tijekom 12 mjeseci.
Rezultati su pokazali da je 39 (79,59%) bolesnika preživjelo na prvom biološkom lijeku 12 mjeseci. Od preživjelih bolesnika je, prema EULAR-ovim smjernicama, remisiju postiglo 20 (51,28%) bolesnika, a nisku aktivnost bolesti 6 (15,38%). Najčešći razlog prekida terapije bila je primarna nedjelotvornost lijeka (70%), a udio nuspojava u ukupnom uzorku iznosila je 28,57%. Uspoređujući dvije skupine lijekova, skupina lijekova drugog mehanizma djelovanja, pokazala je veći broj bolesnika koji su na prvom biološkom lijeku preživjeli 12 mjeseci (86,67% vs 76,47%) te veću prosječnu promjenu aktivnosti bolesti kod tih bolesnika (ΔDAS28 3,65 vs 2,95).

Abstract (english)

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease of unknown cause, which primary affects joints, but can also affect other organic systems. The main feature of RA is a persistent symmetric synovitis that affects distal joints of extremities. Standard treatment include variety of drugs – analgesics, NSARs, glucocorticoids (GC) and DMARDs. By definition of HALMED, biological drugs are drugs which active substance is made or produce by biological source – human, animal or microbiologic. In Republic of Croatia, approved and the most commonly used biologic and targeted synthetic DMARDs are TNF-α inhibitors, IL-6 inhibitors, inhibitors of lymphocytes type B and JAK inhibitors.
The aim of this study was to determine how many patients treated with biological drugs survived 12 months on a therapy with first biologic drugs, and what was the outcome of a disease. Other aims were to evaluate the frequency and reasons of discontinuation of a therapy, frequency of side effects and comparison of two groups of drugs (TNF-α inhibitors and other ihibitors).
This study included 49 patients with RA with an average age of 49,63 (± 12,12),and average duration of illness before treatment with biologic drugs 11.31 ± 6.55 years. In the analyzed group, 34 (69,39%) of patients started biologic treatment with TNF-α inhibitors, whereas 15 (30,61%) of patients started their treatment using some other biological drugs (IL-6 inhibitors, inhibitors of lymphocytes type B and JAK inhibitors). The course of therapy on the first biologic drug was monitored for a period of 12 months.
Results showed that 39 (79,59%) of patients survived 12 months being treated with biologic drug. From the survivors, following EULAR guidelines, remission is established in 20 (51,28%) of patients, whereas 6(15,38%) of patients showed low activity of a disease. The most common reason of discontinuation of treatment was primary inefficient of a drug (70%). The percentage of side effects was 28,57%. Comparing two groups of drugs, group of other inhibitors (non TNF-α inhibitors) showed higher percentage of patients who survived 12 months on a therapy (86,67% vs 76,47%). Results also showed greater alteration of disease activity in patients using non TNF-α inhibitors (ΔDAS28 3,65 vs 2,95)

• Keywords: reumatoidni artritis; RA; autoimunosna bolest; zglobovi; biološki lijek
• Keywords (english): rheumatoid arthritis; RA; autoimmune disease; joints; biologic drugs
• Language: croatian
• URN:NBN: urn:nbn:hr:105:647515
• Study programme: Title: Medicine; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: doktor/doktorica medicine (doktor/doktorica medicine)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access; Embargo expiration date: 2020-10-15
• Public note: Ključne riječi oblikovao urednik
• Created on: 2020-03-11 15:06:21