Učinkovitost bioloških lijekova u bolesnika s reumatoidnim artritisom – iskustva jednog centra

Marijana Šupe, Ana Gudelj Gračanin, Marko Lucijanić, Jadranka Morović-Vergles

In the case of ineffectiveness of synthetic disease-modifying anti-rheumatic drugs (DMARDs) in the treatment of patients with active rheumatoid arthritis (RA), we can use one of the biological or biosimilar drugs according to the Croatian Society for Rheumatology guidelines from 2013. Despite the achieved remission and better disease control, according to literature data up to 60% of patients develop primary or secondary ineffectiveness of the drug. In order to determine primary or secondary ineffectiveness of the drug in our patients, we retrospectively analyzed data from patients treated with biological drugs at the Division of Clinical Immunology, Allergology, and Rheumatology of the Department of Internal Medicine of the University of Zagreb School of Medicine, Clinical Hospital Dubrava, in the period 2008–2016. The study included 88 patients, 25 men and 63 women. The activity of the disease was monitored using the DAS28(CRP) index. In 39 patients (44%), 10 men and 29 women, the first biological drug was replaced with another. Out of these 39 patients, 30 (77%) achieved remission on the second line of treatment. Seven (18%) patients had to be given a third biological drug because of the ineffectiveness of the second drug, while two patients had to be given a fourth or fifth biological drug. The most common cause of discontinuation of the drug was clinical ineffectiveness, which means that the high activity of the disease was maintained. We did not find a statistically significant difference in the titer of rheumatoid factor (RF) and/or anti-citrulatory peptide (anti-CCP) or smoking status in patients treated with a single biological agent and those in which two or more biological drugs had to be used.

Pri neučinkovitosti sintetskih lijekova koji modificiraju tijek bolesti (engl. disease-modifying antirheumatic drugs – DMARDs; u tekstu DMARD-i) u liječenju bolesnika s aktivnim reumatoidnim artritisom (RA) možemo primijeniti jedan od bioloških ili biosličnih lijekova prema smjernicama Hrvatskoga reumatološkog društva iz 2013. godine. Unatoč postignutoj remisiji i boljoj kontroli bolesti primarna ili sekundarna neučinkovitost lijeka razvije se, prema literaturnim podacima, čak u 60% bolesnika. Radi utvrđivanja primarne odnosno sekundarne neučinkovitosti lijeka retrospektivno smo analizirali podatke bolesnika liječenih biološkim lijekovima u Zavodu za kliničku imunologiju, alergologiju i reumatologiju Klinike za unutarnje bolesti Medicinskog fakulteta Sveučilišta u Zagrebu, Kliničke bolnice Dubrava, od 2008. do 2016. god. Aktivnost bolesti praćena je indeksom DAS 28-CRP. U ispitivanje je bilo uključeno 88 bolesnika, 25 muškaraca i 63 žene. U 39 bolesnika (44%), 10 muškaraca i 29 žena, prvi biološki lijek zamijenjen je drugime. Od 39 bolesnika, njih 30 (77%) postiglo je remisiju na primijenjeni drugi biološki lijek, a u sedam bolesnika (18%) zbog neučinkovitosti lijeka uveden je treći biološki lijek, dok je u dva bolesnika uveden i četvrti, odnosno peti lijek. Najčešći razlog prekida primjene lijeka bila je klinička neučinkovitost (visoka aktivnost bolesti). Nismo pronašli statistički značajnu razliku u titru reumatoidnog faktora, anticitrulinskih protutijela ni pušačkog statusa u bolesnika liječenih jednim biološkim lijekom i onih liječenih drugim, trećim ili većim brojem bioloških lijekova.