Evaluation of the Efficacy of Combined Therapy of Methotrexate and Etanercept versus Methotrexate as a Mono-Therapy

AIM: This study aims to evaluate the efficacy of Methotrexate (MTX) alone and combined therapy with Etanercept (ETN) and Methotrexate in patients with active rheumatoid arthritis (RA).METHODS: In the randomised control study, conducted in the period from March 2014 until March 2016, we evaluated the efficacy of the treatment of patients with RA with MTX as monotherapy and combination treatment with MTX and ETN. In the Clinic of Rheumatology in Prishtina, 90 adult patients with RA were treated in combination with ETN (doses of 50 mg subcutaneously/weekly), with oral MTX (doses up to 20 mg weekly), and MTX alone (doses up to 20 mg weekly) during this period of two years. Clinical response was assessed using European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) Criteria and the Disease Activity Score (DAS28). Radiographic changes were measured in the beginning and at the end of the study using Larsen’s method.RESULTS: Of the cohort groups of 90 patients, mean age of 55.63, 15 patients, (16.6 %) were treated with combined therapy (ETN plus MTX) and 75 patients (83.3%) with monotherapy (MTX). After two years of treatment the group with combined therapy resulted with improvement of acute phase reactants as erythrocyte sedimentation rate (ESR) for the first hour (41.1 vs. 10.3 mm/hour) and C - reactive protein (CRP) (40.8 vs. 6 mg/liter), and compared to the group treated with monotherapy, there were no significant changes (ESR: 45.7 vs 34.3 mm/hour; CRP: 48 vs 24 mg/liter). Before the treatment, the severity of the disease was high, wherein the group with combined therapy DAS28 was 5.32, compared to the monotherapy group whom DAS28 was 5.90. After 2 years of treatment, we had significant changes in the results of DAS28, wherein the group treated with ETN plus MTX DAS28 was 2.12 ± 0.15, while in the group of patients treated with MTX DAS28 were 3.75 ± 0.39 (t = 13.03; df = 58; p < 0.0001). The group with combined therapy showed no evidence of radiographic progression comparing to the group of patients with monotherapy.CONCLUSIONS: Based on our results achieved during 2 years we can conclude that ETN in combination with MTX reduced disease activity, slowed radiographic progression and improved clinical manifestations more effectively than MTX alone. No serious adverse events were noticed in the group with combination treatment

REUMATOIDNI ARTRITIS KASNOG NASTUPA: OPSERVACIJSKA STUDIJA

Reumatoidni artritis (RA) može imati početak u starijoj životnoj dobi. Nastup bolesti sa 60 i više godina naziva se RA kasnog početka (engl. Late-Onset Rheumatoid Arthritis – LORA). Cilj ove studije bio je analizirati klinička, laboratorijska, radiološka obilježja i obilježja liječenja u bolesnika s LORA-om u usporedbi s RA ranijeg početka (engl. Early-Onset Rheumatoid Arthritis – EaORA) s tim da su pacijenti u obje grupe bili približno jednakog trajanja bolesti. Radi se o opservacijskoj studiji provedenoj u jednome reumatološkom centru, koja je uključila 120 bolesnika s utvrđenom dijagnozom RA podijeljenih u dvije grupe: 60 bolesnika s LORA-om (istraživana grupa) i 60 bolesnika s EaORA-om (kontrolna skupina). Aktivnost bolesti, mjerena Disease Activity Score 28 (DAS28SE) bila je značajno viša u grupi LORA u odnosu prema grupi EaORA (p < 0,05). Značajno više bolesnika u grupi LORA imalo je zahvaćena ramena (LORA vs. EaORA, 30% vs. 15%; p < 0,05) i koljena (LORA vs. EaORA, 46,7% vs. 16,7%; p < 0,05). Radiološke erozivne promjene bile su značajno češće vidljive u grupi LORA u usporedbi s grupom EaORA (p 0,05), dok je broj pacijenata s pozitivnim nalazom anticitrulinirajućih protutijela (ACPA) bio značajno veći u grupi EaORA (p < 0,05). Vrijednosti C-reaktivnog proteina (CRP) i brzina sedimentacije eritrocita (SE) bile su značajno više/brže u grupi LORA u odnosu prema grupi EaORA. Hemoglobin je bio niži u grupi LORA (11,96 ± 1,64 g/dl) nego u grupi EaORA (12,18 ± 1,56 g/dl). Najčešće primijenjeni lijekovi koji mijenjaju tijek upalnih reumatskih bolesti bili su metotreksat i sulfasalazin, dok biološki lijekovi nisu bili upotrijebljeni. U zaključku, na temelju rezultata iz našeg istraživanja, bolesnici s LORA-om imaju neka obilježja koja se razlikuju od onih u bolesnika s EaORA-om, kao što su viša aktivnost bolesti, češća zahvaćenost velikih zglobova i veće strukturne promjene. Ovo se mora uzeti u obzir u kliničkom radu, napose u odabiru terapije.Rheumatoid arthritis (RA) may have an onset at older age. Th e onset of the disease at the age of 60 and over is called late-onset rheumatoid arthritis (LORA). Th e aim of this study was to analyze the clinical, laboratory, radiological, and treatment characteristics of patients with LORA compared to those with early-onset RA (EaORA), provided that all the patients had an approximately equal duration of the disease. Th is is an observational single-center study, which involved 120 patients with an established diagnosis of RA, of which 60 patients had LORA, and 60 patients EaORA. Th e disease activity, measured by the Disease Activity Score 28 (DAS28-ESR), was signifi cantly higher in the LORA group compared to the EaORA group (p<0.05). Signifi cantly more patients with LORA had involvement of the shoulders (LORA vs. EaORA, 30% vs. 15%; p <0.05) and knees (LORA vs. EaORA, 46.7% vs. 16.7%; p <0.05). Radiological erosive changes were signifi cantly more frequent in the LORA group in comparison with EaORA (p <0.05). Th ere was no diff erence between the groups regarding rheumatoid factor (RF) positivity (p>0.05), while the number of patients positive for anti-citrullinated protein antibody (ACPA) was signifi cantly greater in the EaORA group (p<0.05). Th e values of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were signifi cantly higher in the LORA than in the EaORA group. Hemoglobin levels were lower in the LORA group (11.96±1.64 g/dL) than in the EaORA group (12.18±1.56 g/dL). Th e most used disease-modifying antirheumatic drugs (DMARDs) were methotrexate and sulfasalazine, while biological drugs were not used. In conclusion, based on the results of our study, LORA has some features that distinguish it from EaORA, such as higher disease activity, more frequent involvement of large joints, and more pronounced structural damage. Th is should be taken in account in clinical practice, especially regarding treatment choices

REUMATOIDNI ARTRITIS KASNOG NASTUPA: OPSERVACIJSKA STUDIJA

Reumatoidni artritis (RA) može imati početak u starijoj životnoj dobi. Nastup bolesti sa 60 i više godina naziva se RA kasnog početka (engl. Late-Onset Rheumatoid Arthritis – LORA). Cilj ove studije bio je analizirati klinička, laboratorijska, radiološka obilježja i obilježja liječenja u bolesnika s LORA-om u usporedbi s RA ranijeg početka (engl. Early-Onset Rheumatoid Arthritis – EaORA) s tim da su pacijenti u obje grupe bili približno jednakog trajanja bolesti. Radi se o opservacijskoj studiji provedenoj u jednome reumatološkom centru, koja je uključila 120 bolesnika s utvrđenom dijagnozom RA podijeljenih u dvije grupe: 60 bolesnika s LORA-om (istraživana grupa) i 60 bolesnika s EaORA-om (kontrolna skupina). Aktivnost bolesti, mjerena Disease Activity Score 28 (DAS28SE) bila je značajno viša u grupi LORA u odnosu prema grupi EaORA (p < 0,05). Značajno više bolesnika u grupi LORA imalo je zahvaćena ramena (LORA vs. EaORA, 30% vs. 15%; p < 0,05) i koljena (LORA vs. EaORA, 46,7% vs. 16,7%; p < 0,05). Radiološke erozivne promjene bile su značajno češće vidljive u grupi LORA u usporedbi s grupom EaORA (p 0,05), dok je broj pacijenata s pozitivnim nalazom anticitrulinirajućih protutijela (ACPA) bio značajno veći u grupi EaORA (p < 0,05). Vrijednosti C-reaktivnog proteina (CRP) i brzina sedimentacije eritrocita (SE) bile su značajno više/brže u grupi LORA u odnosu prema grupi EaORA. Hemoglobin je bio niži u grupi LORA (11,96 ± 1,64 g/dl) nego u grupi EaORA (12,18 ± 1,56 g/dl). Najčešće primijenjeni lijekovi koji mijenjaju tijek upalnih reumatskih bolesti bili su metotreksat i sulfasalazin, dok biološki lijekovi nisu bili upotrijebljeni. U zaključku, na temelju rezultata iz našeg istraživanja, bolesnici s LORA-om imaju neka obilježja koja se razlikuju od onih u bolesnika s EaORA-om, kao što su viša aktivnost bolesti, češća zahvaćenost velikih zglobova i veće strukturne promjene. Ovo se mora uzeti u obzir u kliničkom radu, napose u odabiru terapije.Rheumatoid arthritis (RA) may have an onset at older age. Th e onset of the disease at the age of 60 and over is called late-onset rheumatoid arthritis (LORA). Th e aim of this study was to analyze the clinical, laboratory, radiological, and treatment characteristics of patients with LORA compared to those with early-onset RA (EaORA), provided that all the patients had an approximately equal duration of the disease. Th is is an observational single-center study, which involved 120 patients with an established diagnosis of RA, of which 60 patients had LORA, and 60 patients EaORA. Th e disease activity, measured by the Disease Activity Score 28 (DAS28-ESR), was signifi cantly higher in the LORA group compared to the EaORA group (p<0.05). Signifi cantly more patients with LORA had involvement of the shoulders (LORA vs. EaORA, 30% vs. 15%; p <0.05) and knees (LORA vs. EaORA, 46.7% vs. 16.7%; p <0.05). Radiological erosive changes were signifi cantly more frequent in the LORA group in comparison with EaORA (p <0.05). Th ere was no diff erence between the groups regarding rheumatoid factor (RF) positivity (p>0.05), while the number of patients positive for anti-citrullinated protein antibody (ACPA) was signifi cantly greater in the EaORA group (p<0.05). Th e values of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were signifi cantly higher in the LORA than in the EaORA group. Hemoglobin levels were lower in the LORA group (11.96±1.64 g/dL) than in the EaORA group (12.18±1.56 g/dL). Th e most used disease-modifying antirheumatic drugs (DMARDs) were methotrexate and sulfasalazine, while biological drugs were not used. In conclusion, based on the results of our study, LORA has some features that distinguish it from EaORA, such as higher disease activity, more frequent involvement of large joints, and more pronounced structural damage. Th is should be taken in account in clinical practice, especially regarding treatment choices