Browsing by Author "Dalkiliç, E"
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Item A real-life analysis of patients with rheumatologic diseases on biological treatments: Data from TURKBIO RegistryÖnen, F; Can, G; Çapar, S; Dalkiliç, E; Pehlivan, Y; Senel, S; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanç, N; Sari, I; Birlik, M; Solmaz, D; Cefle, A; Öztürk, MA; Yolbas, S; Krogh, NS; Yilmaz, N; Erten, S; Bes, C; Gündüz, ÖS; Göker, B; Haznedaroglu, S; Yavuz, S; Çetin, GY; Yildiz, F; Direskeneli, H; Akkoç, NObjective: TURKBIO registry, established in 2011, is the first nationwide biological database in Turkey. This study aimed to provide an overview of TURKBIO data collected by June 2018. Methods: The registry included adult patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-AxSpA), and psoriatic arthritis (PsA). Demographic and clinical features, disease activity markers, and other follow-up parameters, current and previous treatments, and adverse events were registered electronically at each visit using open-source software. The registration of patient-reported outcome measures was carried out electronically by the patients using touch screens. Results: TURKBIO registry included a total of 41,145 treatment series with biologicals. There were 2,588 patients with axSpA (2,459 AS and 129 nr-axSpA), 2,036 with RA, and 428 with PsA. The total number of patients, including those with other diagnoses, was 5,718. In the follow-up period, the number of patients and also visits steadily increased by years. The yearly mean number of visits per patient was found to be 2.3. Significant improvements in disease activity and health assessment parameters were observed following the biological treatments. Biologics were often given in combination with a conventional synthetic disease-modifying antirheumatic drug in patients with RA. Infections were the most commonly seen adverse events, followed by allergic reactions. Tuberculosis was observed in 12 patients, malignancy in 18, and treatment-related mortality in 31. Conclusion: TURKBIO provided a valuable real-life experience with the use of biologics in rheumatic diseases in Turkey.Item UNINTENTIONAL MONOTHERAPY IN RHEUMATOID ARTHRITIS PATIENTS RECEIVING TOFACITINIB AND DRUG SURVIVAL RATE OF TOFACITINIBInanc, N; Abacar, K; Ozturk, MA; Tufan, A; Karadeniz, H; Sari, I; Can, G; Erez, Y; Pehlivan, Y; Dalkiliç, E; Ocak, T; Cefle, A; Yazici, A; Senel, A; Akar, S; Ediboglu, ED; Koca, SS; Sagir, RP; Yilmaz, S; Gulcemal, S; Gündüz, ÖS; Basibüyük, CS; Alkan, S; Cesur, TY; Onen, FItem A national, multicenter, secondary data use study evaluating efficacy and retention of first-line biologic treatment with tocilizumab in patients with rheumatoid arthritis in real-life setting: results from TURKBIO registryYazici, A; Isik, ÖÖ; Dalkiliç, E; Koca, SS; Pehlivan, Y; Senel, S; Inanc, N; Akar, S; Yilmaz, S; Gündüz, ÖS; Cefle, A; Karakas, ÖF; Onen, FTocilizumab (TCZ) is a recombinant humanized monoclonal antibody that targets the IL-6 receptor. TCZ found to be efficacious and has a good tolerated safety profile in rheumatoid arthritis (RA) patients. The aim of this study was to describe the disease activity and retention rate in Turkish RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting. Secondary data obtained from adult RA patients' files was used in a multicenter and retrospective context. Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints with ESR (DAS28-ESR), and retention rates of TCZ were evaluated at related time points. 130 patients (87.7% female) with a mean age of 53 years (SD; 15.0) were included in the study. Mean RA duration was 14 years and median duration of follow-up was 18.5 months. Number of patients with ongoing TCZ treatment at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (<2.8) and DAS28-ESR (<2.6) scores were 61.5, 44.6, 30%, and 54.6, 40.8, 27.7%, respectively. Both CDAI and DAS28-ESR scores significantly improved at 6, 12 and 24 months (p<0.001 for both). At 24 months, 23 patients (17.6%) discontinued TCZ, of whom majority (17/23) were due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93, 84.3, and 72.2%, respectively. In this real-world study, TCZ as a first-line biologic therapy was found to be efficacious and showing high retention rates. These real-world study results are in line with previous randomized studies.Item THE EFFICACY AND SAFETY OF ANTI-TNF A TREATMENT IN ANKYLOSING SPONDYLITIS PATIENTS WITH LATE ONSET COMPARED TO THOSE WITH ADULT ONSET; THE DATA FROM TURKBIO REGISTRYUslu, S; Can, G; Cefle, A; Yilmaz, S; Kocaer, SB; Inel, TY; Gülle, S; Koca, SS; Yolbas, S; Öztürk, MA; Senel, S; Inanc, N; Dalkiliç, E; Soysal, O; Tufan, A; Akar, S; Birlik, M; Sari, I; Akkoc, N; Onen, FItem Biological treatment in elderly and young patients with ankylosing spondylitis: TURKBIO real-life data resultsUslu, S; Gülle, S; Urak,Ö; Sen, G; Dalkiliç, E; Senel, S; Akar, S; Inanç, N; Cefle, A; Avsar, AK; Yolbas, S; Yilmaz, S; Gündüz, OS; Sari, I; Birlik, M; Akkoç, N; Önen, FObjectives: This study aims to investigate the effect of age on disease activity and biological treatment in patients with ankylosing spondylitis (AS). Patients and methods: A total of 811 AS patients registered in the TURKBIO registry database between 2011 and 2019 were categorized according to their age at the time of entry into the registry and assigned to one of two groups: young patients, defined as <60 years of age (n=610), and those aged >= 60 years (n=201) were recorded as elderly patients. Demographic, clinical, and laboratory characteristics, along with disease activity markers and other follow-up parameters, as well as current and prior treatments, were electronically recorded during each visit using open -source software. Results: The mean age of the elderly patients was 67 +/- 5.8 years, while the mean age of the younger patients was 49.2 +/- 10.9 years. Male predominance was lower in the older AS group compared to the younger AS group (p=0.002). During follow-up period, 397 patients (comprising 318 young and 79 elderly individuals) had a history of using at least one biological disease -modifying agent (bDMARD). There was no significant difference between the groups in terms of DMARD and bDMARD-use distributions. First tumor necrosis factor inhibitor (TNFi) retention rates were found to be similar in both groups over 10 years of follow-up. Adverse events were found to be similar in young (19.9%) and elderly (26.8%) AS patients. Conclusion: Research in the TURKBIO cohort reveals that both older and younger patients with AS exhibited similar disease activity levels with comparable treatment approaches. Moreover, the results of TNFi treatments in elderly patients were the same as those observed in younger patients, with no notable increase in safety concerns.Item The Efficacy and Safety of Anti-TNFα Treatment in Ankylosing Spondylitis Patients with Late Onset Compared to Those with Adult Onset; The Data from TURKBIO RegistryUslu, S; Can, G; Cefle, A; Yilmaz, S; Kocaer, SB; Inel, TY; Gülle, S; Koca, SS; Yolbas, S; Öztürk, MA; Senel, S; Inanc, N; Dalkiliç, E; Gunduz, O; Tufan, A; Akar, S; Birlik, M; Sari, I; Akkoç, N; Onen, FItem The impact of smoking on response to tumor necrosis factor-α inhibitor treatment in patients with ankylosing spondylitisTugsal, HY; Kenar, G; Can, G; Çapar, S; Zengin, B; Akar, S; Dalkiliç, E; Senel, S; Koca, SS; Goker, B; Yazici, A; Inanç, N; Ellidokuz, H; Akkoç, N; Önen, FBackground/aim: To investigate the impact of smoking on disease activity, treatment retention, and response in patients with ankylosing spondylitis (AS) treated with their first tumor necrosis factor-alpha inhibitor (TNFi). Materials and methods: AS patients who started their first TNFi treatment for the active axial disease (BASDAI >= 4) from TURKBIO Registry were included. Treatment response of smoker (current and ex-smokers) and nonsmoker (never smoker) patients were primarily evaluated as achievement of BASDAI50 or improvement in BASDAI at least 20 mm at 3 months and 6 months compared to baseline. Results: There were 322 patients with AS (60% male, 59% smoker, mean age: 38.3 years). The median follow-up time was 2.8 years (Q1-Q3: 1.3-3.8), and disease duration was 3.5 years (Q1-Q3: 0.7-8.2). Smokers had male predominance (p < 0.001), lower ESR (p = 0.03), higher BASDAI (p = 0.02), BASFI (p = 0.05), HAQ-AS (p = 0.007), and ASDAS-CRP (p = 0.04) compared with nonsmokers at baseline. In the multivariate analysis, male gender [OR 2.7 (95%CI 1.4-5), p = 0.002], and concomitant conventional synthetic disease-modifying antirheumatic drug use [OR 2.4 (95%CI 1.1-5.2), p = 0.03] were associated with better treatment response. There was an association of male gender [HR 2.4 (95%CI 1.6-3.7), p < 0.001], older age (>= 30years) [HR 1.8 (95%CI 1.1-2.8), p = 0.01], and response to treatment [HR 1.8 (95%CI 1.2-2.9), p = 0.008] with better treatment retention. No impact of smoking status was found on treatment retention and response in univariate and multivariate analyses. Conclusion: This study suggested that smoking was associated with poorer patient-reported outcomes in biologic naive AS patients initiating their first TNFi treatment, but it had no impact on the TNFi treatment response and retention rate.Item INCIDENCE OF ANTERIOR UVEITIS IN AXIAL SPONDYLOARTHRITIS DURING SECUKINUMAB TREATMENT: TWO YEARS REAL LIFE EXPERIENCE FROM TURKBIO REGISTRYAkleylek, C; Akar, S; Cinakli, H; Sagir, RP; Coskun, BN; Karakas, A; Apaydin, H; Kardas, RC; Isik, OO; Hakbilen, S; Okyar, B; Sosyal, O; Koca, SS; Pehlivan, Y; Dalkiliç, E; Can, G; Sari, I; Birlik, M; Onen, F; Erten, S; Ozturk, MA; Yazici, A; Cefle, A; Yilmaz, S; Cetin, GY; Akkoc, N; Yilmaz, NItem Body mass index does not affect response of rituximab in patients with rheumatoid arthritis: results from the TURKBİO registryKaratas, A; Piskin Sagir, R; Koca, SS; Dalkiliç, E; Can, G; Pehlivan, Y; Yazici, A; Inanç, N; Cefle, A; Ertürk, Z; Akar, S; Senel, S; Birlik, M; Akkoç, N; Önen, FBackground/aim: Adipose tissue produces several inflammatory mediators. Thus, obesity affects the disease course and the responses to the antirheumatic agents in inflammatory diseases. The aim of the study was to determine whether the body mass index (BMI) is involved in the response to rituximab in rheumatoid arthritis (RA).Materials and methods: This multicenter retrospective study included 206 RA patients who received rituximab from the Turkish Biologic (TURKBIO) registry between 2011 and the end of May 2017. Demographic and clinical data including age, sex, disease type, disease duration, and previous or current treatment with disease-modifying antirheumatic drugs (DMARDs) and biological drug durations are stored in the databse. Patients with a BMI >= 30 kg/m(2) were classified as obese, and patients with a BMI <30 kg/m(2) were classified as nonobese. Kaplan-Meier survival analysis was performed to estimate the drug survival. The subgroups were compared using the log-rank test.Results: The mean BMI of 206 patients included in the study was 27.05 (17.2-43.4) kg/m(2). There were 59 (28.6%) patients in the obese group and 147 (71.4%) patients in the nonobese group. The mean age, female percentage, and baseline disease activity score 28 (DAS28) were higher in the obese group than in the nonobese group. However, the Delta DAS28 at both 6 and 12 months were not significantly different between the groups (p = 0.785 and p = 0.512, respectively). Patient pain Visual Analogue Scale (VAS), patient fatigue VAS, and patient global VAS scores were also significantly higher at baseline in the obese group (p = 0.003, p = 0.006, and p = 0.006, respectively). However, no significant difference was found in terms of changes in patient pain VAS, patient fatigue VAS, patient global VAS and physician global VAS scores at 6 and 12 months compared to those at baseline. Rituximab treatment was ongoing for 71.2% of the obese and 63.3% of the nonobese patients (p = 0.279). The median drug survival duration was 77 months in the obese group and 62 months in the nonobese group (p = 0.053). The estimated drug survival rates for rituximab were not statistically significantly different in the obese and nonobese groups. Rituximab-related side effects were also similar between the groups.Conclusion: In obese and nonobese patients with RA, rituximab treatment exhibits similar side effects and similar long-term efficacy. These results suggest that obesity does not alter drug survival for rituximab and response rates, in RA and rituximab may be a favorable treatment agent in patients with RA and obesity.Item LONG-TERM SURVIVAL OF THE FIRST BIOLOGIC TREATMENT IN PSORIATIC ARTHRITIS AND THE EFFECT OF THE SELECTED TREATMENT ON DRUG SURVIVAL; TURKBIO REGISTRYKocaer, SB; Inel, TY; Erez, Y; Avsar, AK; Uslu, S; Karakas, A; Gulle, S; Can, G; Sari, I; Birlik, M; Dalkiliç, E; Pehlivan, Y; Akar, S; Cefle, A; Öztürk, MA; Yolbas, S; Yilmaz, N; Erten, S; Akkoc, N; Onen, FItem Genome-wide association study in Turkish and Iranian populations identify rare familial Mediterranean fever gene (MEFV) polymorphisms associated with ankylosing spondylitisLi, ZX; Akar, S; Yarkan, H; Lee, SK; Çetin, P; Can, G; Kenar, G; Çapa, F; Pamuk, ON; Pehlivan, Y; Cremin, K; De Guzman, E; Harris, J; Wheeler, L; Jamshidi, A; Vojdanian, M; Farhadi, E; Ahmadzadeh, N; Yüce, Z; Dalkiliç, E; Solmaz, D; Akin, B; Dönmez, S; Sari, I; Leo, PJ; Kenna, TJ; Önen, F; Mahmoudi, M; Brown, MA; Akkoc, NAnkylosing spondylitis (AS) is a highly heritable immune-mediated arthritis common in Turkish and Iranian populations. Familial Mediterranean Fever (FMF) is an autosomal recessive autoinflammatory disease most common in people of Mediterranean origin. MEFV, an FMF-associated gene, is also a candidate gene for AS. We aimed to identify AS susceptibility loci and also examine the association between MEFV and AS in Turkish and Iranian cohorts. We performed genome-wide association studies in 1001 Turkish AS patients and 1011 Turkish controls, and 479 Iranian AS patients and 830 Iranian controls. Serum IL-1, IL-17 and IL-23 cytokine levels were quantified in Turkish samples. An association of major effect was observed with a novel rare coding variant in MEFV in the Turkish cohort (rs61752717, M694V, OR = 5.3, P = 7.63x10(-12)), Iranian cohort (OR = 2.9, P = 0.042), and combined dataset (OR = 5.1, P = 1.65x10(-13)). 99.6% of Turkish AS cases, and 96% of those carrying MEFV rs61752717 variants, did not have FMF. In Turkish subjects, the association of rs61752717 was particularly strong in HLA-B27-negative cases (OR = 7.8, P = 8.93x10(-15)), but also positive in HLA-B27-positive cases (OR = 4.3, P = 7.69x10(-8)). Serum IL-1, IL-17 and IL-23 levels were higher in AS cases than controls. Among AS cases, serum IL-1 and IL-23 levels were increased in MEFV 694V carriers compared with non-carriers. Our data suggest that FMF and AS have overlapping aetiopathogenic mechanisms. Functionally important MEFV mutations, such as M694V, lead to dysregulated inflammasome function and excessive IL-1 function. As IL-1 inhibition is effective in FMF, AS cases carrying FMF-associated MEFV variants may benefit from such therapy. Author summary Ankylosing spondylitis (AS) is a highly heritable immune-mediated arthritis. To identify new genetic associations with AS, we performed genome-wide association studies in Turkish and Iranian AS patients and controls. We identified a novel rare coding MEFV variant associated with AS. Rare polymorphisms of MEFV, which encodes the protein pyrin, are known to cause Familial Mediterranean Fever (FMF), a monogenic, autosomal recessive, autoinflammatory disease which can be complicated by arthritis. 99.6% of Turkish AS cases, and 96% of those carrying the MEFV variant, did not have FMF, and the association with AS remains excluding cases with FMF. In Turkish subjects, the MEFV variant association was particularly strong in HLA-B27-negative cases, but also positive in HLA-B27-positive cases. This represents the first rare variant association with AS, and has the highest odds ratio for AS of any non-MHC reported hitherto, indicating a major effect on disease pathogenesis. We assessed serum cytokine levels in the cohort, and found that IL-1, IL-17 and IL-23 levels were higher in AS cases. Furthermore, among AS cases, IL-1 and IL-23 levels were increased in MEFV variant carriers compared with non-carriers. This study has therapeutic implications; as IL-1 inhibition is effective in FMF, AS cases carrying FMF-associated MEFV variants may benefit from such therapy.Item A NATIONAL, MULTICENTER, SECONDARY DATA USE STUDY EVALUATING EFFICACY AND RETENTION OF FIRST-LINE BIOLOGIC TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-LIFE SETTING FROM TURKBIO REGISTRYYazici, A; Isik, OO; Dalkiliç, E; Koca, SS; Pehlivan, Y; Senel, S; Inanc, N; Akar, S; Yilmaz, S; Gündüz, ÖS; Cefle, A; Onen, FItem DO COMORBIDITIES IMPACT PERSISTENCE OF FIRST TUMOR NECROSIS FACTOR INHIBITOR TREATMENT IN RHEUMATOID ARTHRITIS? DATA FROM TURKBIOInel, TY; Kocaer, SB; Erez, Y; Gulle, S; Karakas, A; Avsar, AK; Uslu, S; Can, G; Sari, I; Birlik, M; Dalkiliç, E; Pehlivan, Y; Akar, S; Goker, B; Cetin, GY; Haznedaroglu, S; Yavuz, S; Pirildar, T; Direskeneli, H; Akkoc, N; Onen, FItem DO COMORBIDITIES DECREASE THE FIRST TNF-INHIBITOR RETENTION AND TREATMENT RESPONSE IN AXIAL SPONDYLOARTHRITIS PATIENTS? DATA FROM TURKBIOErez, Y; Karakas, A; Kocaer, SB; Inel, TY; Gulle, S; Avsar, AK; Uslu, S; Can, G; Sari, I; Birlik, M; Dalkiliç, E; Pehlivan, Y; Senel, S; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanc, N; Solmaz, D; Akkoc, N; Onen, FItem Impact of rheumatoid arthritis in Turkey: a questionnaire studyDireskeneli, H; Akkoç, N; Bes, C; Çakir, N; Çefle, A; Çobankara, V; Dalkiliç, E; Dinç, A; Ertenli, T; Gül, A; Hamuryudan, V; Inanç, M; Kalyoncu, U; Karaaslan, Y; Kasifoglu, T; Keser, G; Keskin, G; Kisacik, B; Kiraz, S; Masatlioglu, S; Onat, AM; Özbek, S; Öztürk, MA; Pamuk, ÖN; Pay, S; Pirildar, T; Sayarlioglu, M; Senel, S; Sentürk, T; Tasan, D; Terzioglu, E; Yazici, A; Yücel, EObjective Unmet needs of rheumatoid arthritis (RA) patients regarding physician/patient communication, treatment preferences and quality of life issues were investigated in a Turkish survey study. Methods The study was conducted with the contribution of 33 rheumatologists, and included 519 RA patients. The study population included patients who had been on biologic therapy for >6 months and were still receiving biologic therapy (BT group), and those who were biologic naive, but found eligible for biologic treatment (NBT group). Of the RA patients, 35.5% initially had a visit to an internal disease specialist, 25.5% to a physical therapy and rehabilitation specialist, and 12.2% to a rheumatology specialist for their RA complaints. The diagnosis of RA was made by a rheumatologist in 48.2% of patients. Results The majority of RA patients (86.3%) visit their doctor within 15-week intervals. Most of the physician-patient communication focused on disease symptoms (99.0%) and impact of the disease on quality of life (61.8%). The proportion of RA patients who perceived their health status as good/very good/excellent was higher in the BT group than in the NBT group (74.3% vs. 51.5%, p<0.001). However, of those RA patients in the NBT group, only 24.8% have been recommended to start a biologic treatment by their doctors. With respect to dose frequency options, once-monthly injections were preferred (80%) to a bi-weekly injection schedule (8%). Conclusion In conclusion, RA patients receiving biologic therapy reported higher rates of improved symptoms and better quality of life and seemed to be more satisfied with their treatment in our study.