| Sažetak | Biološki lijekovi su skupina novih lijekova antiinflamatornog i imunosupresivnog djelovanja koji su ciljano stvarani u biološkim sustavima. U ovom istraživanju prikupljeni su podaci o svim bolesnicima liječenima biološkom terapijom u Zavodu za kliničku imunologiju i reumatologiju KBC-a Zagreb od lipnja 2006. do srpnja 2012. godine. Rezultati su pokazali da od ukupno 164 bolesnika liječenih biološkom terapijom 113 (68,9%) čine žene a 51 (31,1%) muškarci. Prosječna dob žena u skupini je 49,02, a muškaraca 45,65 godina. Najveći udio u morbiditetu skupine ima reumatoidni artritis (89/164) uz ankilozantni spondilitis (37/164) te psorijatični artritis (23/164). Prosječno vrijeme od postavljanja dijagnoze do početka primjene biološke terapije u mjesecima je 78,7. U skupini koja boluje od RA korišteni su infliksimab (IFX)(31/102), etanercept (ETN)(29/102), adalimumab (ADA)(24/102), tocilizumab (TCZ)(8/102), golimumab (GOL)(7/102) te rituksimab (RTX)(3/102). U skupini bolesnika s AS korišteni su IFX (12/39), ADA (12/39), ETN (11/39), GOL (4/39). Bolesnici s PsA dobivali su ETN (9/25), ADA (9/25), IFX (6/25), GOL(1/25). Bolesnici dijagnozom juvenilnog kroničnog artritisa (JKA) primali su ETN (6/18), TCZ (4/18), ADA (3/18), IFX (3/18) te abatacept (ABA)(2/18). U skupini ostalih i preklapajućih upalnih reumatskih bolesti korišteni su TCZ (3/11), ADA (2/11), GOL (2/11), ETN (2/11), anakinra (ANA)(1/11) te IFX (1/11). Kod 19 ispitanika uvedena je druga linija biološke terapije („switch“). Najčešća dijagnoza među njima je RA (8/19), a potom JKA (5/19). Najčešći razlog promjene biološkog lijeka bio je početni izostanak ili naknadno slabljenje učinka. Kod 30 bolesnika došlo je do trajnog prekida biološke terapije, a glavni razlozi bili su neprimjerena suradljivost bolesnika (9/30) te razvoj nuspojava (8/30). Zabilježeno je i 14 privremenih prekida biološke terapije, najčešće zbog infekcija (7/14), kemoprofilakse tuberkuloze (2/14) te operacija (2/14). Zaključno, odluka o uvođenju biološke terapije u većini se slučajeva donosi kod bolesnika kod kojih su iscrpljene druge mogućnosti liječenja. Skupoća, nuspojave te potreba za čestim hospitalizacijama predstavljaju neke od negativnih strana biološke terapije. Međutim, broj bolesnika na biološkoj terapiji neprestano raste dokazujući time svoju učinkovitost i opravdanost primjene u bolesnika kod kojih je to indicirano. |
| Sažetak (engleski) | Biological drugs are a group of new antiinflammatory and immunosuppressive drugs specifically developed in the biological systems. In this research, data were collected on all patients treated with biological therapy in the Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, School of Medicine, University Hospital Center Zagreb from June 2006 to July 2012. The results showed that, among 164 patients treated with biologic therapy, 113 (68.9%) were women and 51 (31.1%) men. The mean age of women was 49.02, and of men 45.65 years. The largest share of the group morbidity suffers from rheumatoid arthritis (89/164), followed by ankylosing spondylitis (37/164) and psoriatic arthritis (23/164). The average disease duration before the first application of the biological therapy was 78.7 months. In the group suffering from RA the patients were treated with infliximab (IFX) (31/102), etanercept (ETN) (29/102), adalimumab (ADA) (24/102), tocilizumab (TCZ) (8/102), golimumab (GOL) (7/102) and rituximab (RTX) (3/102). Patients with AS were administered IFX (12/39), ADA (12/39), ETN (11/39), GOL (4/39). Patients with PsA received ETN (9/25), ADA (9/25), IFX (6/25), GOL (1/25). Patients diagnosed with juvenile chronic arthritis (JKA) received ETN (6/18), TCZ (4/18), ADA (3/18), IFX (3/18) and abatacept (ABA) (2/18). In the group of other rheumatic disesases and overlapping inflammatory rheumatic diseases patients were treated with TCZ (3/11), ADA (2/11), GOL (2/11), ETN (2/11), anakinra (ANA) (1/11) and IFX (1/11). In 19 patients a second-line biological therapy was intoduced ("switch"). These patients were most commonly diagnosed with RA (8/19) and JKA (5/19). The most common reason for the switch was primary or secondary loss of efficacy (18/38). Thirty patients permanently discontinued the biological therapy and the main reasons were inadequate patient compliance (9/30) and adverse effects (8/30). Fourteen temporary discontinuitations of biological therapy were reported, most commonly due to infection (7/14), tuberculosis chemoprophylaxis (2/14) and operations (2/14). In conclusion, the biological therapy is mostly introduced in patients who have not responded to other treatment options. High costs, adverse effects and frequent hospitalizations represent some of the negative aspects of biological therapy. However, the number of patients on biological therapy is increasing, proving its effectiveness and validity in patients who have the indication. |
