Browsing by Author "Akkoç, N"

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    Comparative Efficacy of Biologic Disease-Modifying Anti-Rheumatic Drugs for Non-Radiographic Axial Spondyloarthritis: A Systematic Literature Review and Bucher Indirect Comparisons
    Akkoç, N; Arteaga, CH; Auteri, SE; Betts, M; Fahrbach, K; Kim, M; Kiri, S; Neupane, B; Gaffney, K; Mease, PJ
    Introduction: Biologic disease-modifying anti-rheumatic drugs (bDMARDs), including certolizumab pegol (CZP), are effective treatment options for the management of non-radiographic spondyloarthritis (nr-axSpA). In the absence of head-to-head comparisons in nr-axSpA, we conducted a systematic literature review (SLR) and indirect treatment comparison (ITC) to better understand the comparative efficacy of CZP vs. other bDMARDs.Methods: Literature searches were conducted in October 2020 in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials in patients with nr-axSpA who had failed at least one non-steroidal anti-inflammatory drug and were treated with bDMARDs. Outcomes of interest included the Assessment of Spondyloarthritis international Society (ASAS), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI) and Disease Activity Index (BASDAI), and spinal pain score. Comparative efficacy was examined using a series of Bucher ITCs in subgroups matched by prior exposure to bDMARDs, disease duration, baseline C-reactive protein (CRP) levels/magnetic resonance imaging (MRI) status, and timepoints, to ensure comparability between studies.Results: At 12-16 weeks, treatment with CZP was significantly more likely to achieve ASAS20/40 response and ASDAS-inactive disease status vs. etanercept (ETN), ixekizumab (IXE), and secukinumab (SEC). CZP showed statistically significant improvement in BASDAI, BASFI, and total spine pain score over adalimumab (ADA), ETN, and IXE, and in BASFI over SEC. Among patients with objective signs of inflammation (OSI; elevated CRP levels and/or inflammation on MRI at baseline), CZP had a statistically significant advantage over ETN and SEC (with or without loading dose) in achieving ASAS40, whereas the comparisons with other bDMARDs did not show any statistically significant differences.Conclusion: In the overall matched population, CZP performed significantly better than most comparators in improving the clinical outcomes. Among patients with OSI, CZP was found to be superior to SEC (in the MRI-/CRP + and MRI + /CRP- subgroups) and ETN (in the MRI + /CRP- subgroup) and it was comparable to golimumab and IXE across the different OSI subgroups.
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    The prevalence of Sjogren's syndrome and sicca symptoms in patients with systemic sclerosis and alpha-smooth muscle actin expression in biopsy specimens from minor salivary glands
    Can, G; Sarioglu, S; Birlik, M; Kenar, G; Soysal, Ö; Solmaz, D; Gerdan, V; Önen, F; Akkoç, N; Akar, S
    Background/aim: This study aimed to investigate the prevalence of sicca symptoms and secondary Sjogren's syndrome (SjS) in patients with systemic sclerosis (SSc). Also this study aimed to evaluate the expression of alpha-smooth muscle actin (alpha-SMA) in minor salivary gland (MSG) specimens, a possible marker of fibrosis responsible for myofibroblastic transformation. Materials and methods: Patients with SSc who were followed in Rheumatology outpatient clinic at a university hospital evaluated. The questionnaire of sicca symptoms and classification of SjS were evaluated according to the American-European Consensus Group (AECG) criteria. Histopathologic evaluations were done in MSG specimens investigating the presence of focal lymphocytic sialadenitis and glandular fibrosis, also assessing the expression of alpha-SMA. Results: This cross-sectional study included 102 patients with SSc [91 females (89%), mean age 52.5 +/- 12 years]. In this cohort 76 (75%) patients had sicca symptoms and 36 (35.3%) patients fulfilled the AECG criteria for SjS; all with limited form. Having SjS found to be associated with older age and the presence of positive anti-SS-A antibodies. On histopathologic examinations, glandular fibrosis was observed in 67 (80%) and lymphocytic sialadenitis was detected in 38 (45%) patients; but only 7 samples were positive for alpha-SMA. Conclusion: This study suggested sicca symptoms were found to be very common among patients with SSc. Also secondary SjS was detected in nearly one-third of patients with SSc; especially in limited subtype. Anti SS-A positivity and older age were detected as predictors for SjS. Histopathologic evaluations showed significant glandular fibrosis but rare alpha-SMA staining in patients with SSc.
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    Musculoskeletal manifestations in children with Behcet's syndrome: data from the AIDA Network Behcet's Syndrome Registry
    Gaggiano, C; Maselli, A; Sfikakis, PP; Laskari, K; Ragab, G; Hegazy, MT; Laymouna, AH; Lopalco, G; Almaghlouth, IA; Asfina, KN; Alahmed, O; Mayrink, HAG; Antonelli, IPD; Cattalini, M; Piga, M; Sota, J; Gentileschi, S; Maggio, MC; Opris-Belinski, D; Hatemi, G; Insalaco, A; Olivieri, AN; Tufan, A; Karadeniz, H; Kardas, RC; La Torre, F; Cardinale, F; Marino, A; Guerriero, S; Ruscitti, P; Tarsia, M; Vitale, A; Caggiano, V; Telesca, S; Iannone, F; Parretti, V; Frassi, M; Aragona, E; Ciccia, F; Wiesik-Szewczyk, E; Ionescu, R; Sahin, A; Akkoç, N; Hinojosa-Azaola, A; Tharwat, S; Hernández-Rodríguez, J; Espinosa, G; Conti, G; Del Giudice, E; Govoni, M; Emmi, G; Fabiani, C; Balistreri, A; Frediani, B; Rigante, D; Cantarini, L
    This study aims to describe musculoskeletal manifestations (MSM) in children with Behcet's syndrome (BS), their association with other disease manifestations, response to therapy, and long-term prognosis. Data were retrieved from the AIDA Network Behcet's Syndrome Registry. Out of a total of 141 patients with juvenile BS, 37 had MSM at disease onset (26.2%). The median age at onset was 10.0 years (IQR 7.7). The median follow-up duration was 21.8 years (IQR 23.3). Recurrent oral (100%) and genital ulcers (67.6%) and pseudofolliculitis (56.8%) were the most common symptoms associated with MSM. At disease onset, 31 subjects had arthritis (83.8%), 33 arthralgia (89.2%), and 14 myalgia (37.8%). Arthritis was monoarticular in 9/31 cases (29%), oligoarticular in 10 (32.3%), polyarticular in 5 (16.1%), axial in 7 (22.6%). Over time, arthritis became chronic-recurrent in 67.7% of cases and 7/31 patients had joint erosions (22.6%). The median Behcet's Syndrome Overall Damage Index was 0 (range 0-4). Colchicine was inefficacious for MSM in 4/14 cases (28.6%), independently from the type of MSM (p = 0.46) or the concomitant therapy (p = 0.30 for cDMARDs, p = 1.00 for glucocorticoids); cDMARDs and bDMARDs were inefficacious for MSM in 6/19 (31.4%) and 5/12 (41.7%) cases. The presence of myalgia was associated with bDMARDs inefficacy (p = 0.014). To conclude, MSM in children with BS are frequently associated with recurrent ulcers and pseudofolliculitis. Arthritis is mostly mono- or oligoarticular, but sacroiliitis is not unusual. Prognosis of this subset of BS is overall favorable, though the presence of myalgia negatively affects response to biologic therapies. ClinicalTrials.gov Identifier: NCT05200715 (registered on December 18, 2021).
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    Impact of HLA-B51 on Uveitis and Retinal Vasculitis: Data from the AIDA International Network Registries on Ocular Inflammatory Disorders
    Sota, J; Guerriero, S; Lopalco, G; Tufan, A; Ragab, G; Almaglouth, I; Govoni, M; Sfikakis, PP; Frassi, M; Vitale, A; Kardas, RC; Triggianese, P; Chimenti, MS; Aboabat, AA; Piga, M; Monti, S; Sebastiani, GD; Yildirim, D; Conforti, A; Gentileschi, S; Dammacco, R; Hinojosa-Azaola, A; Kawakami-Campos, PA; Ruffilli, F; Torres-Ruiz, J; Thabet, M; Atig, A; Ruscitti, P; Cataldi, G; Viapiana, O; Hatemi, G; Karakoç, A; Costi, S; Iagnocco, A; Crisafulli, F; Fragoulis, G; Del Giudice, E; Hegazy, MT; Paroli, MP; Sahin, A; Morrone, M; Iannone, F; Opris-Belinski, D; Asfina, KN; Barone, P; Gaggiano, C; Kucuk, H; Gicchino, MF; Carubbi, F; Caggiano, V; Laskari, K; Tharwat, S; Direskeneli, H; Alibaz-Oner, F; Sevik, G; Maier, A; Laymouna, AH; Emmi, G; Akkoç, N; Tarsia, M; Sbalchiero, J; Conti, G; Spinella, R; La Torre, F; Tombetti, E; Amin, RH; Mauro, A; Karamanakos, A; Carreño, E; Fonollosa, A; Cattalini, M; Breda, L; de-la-Torre, A; Wiesik-Szewczyk, E; Cifuentes-González, C; Ozen, S; Mazzei, MA; Tosi, GM; Frediani, B; Balistreri, A; Batu, ED; Gupta, V; Cantarini, L; Fabiani, C
    PurposeThe clinical relevance of human leukocyte antigen (HLA) subtypes such as HLA-B51 on Beh & ccedil;et's disease (BD)-related uveitis and non-infectious uveitis (NIU) unrelated to BD remains largely unknown.MethodsData were prospectively collected from the International AIDA Network Registry for BD and for NIU. We assessed differences between groups (NIU unrelated to BD and positive for HLA-B51, BD-related uveitis positive for HLA-B51 and BD-related uveitis negative for HLA-B51) in terms of long-term ocular complications, visual acuity (VA) measured by best corrected visual acuity (BCVA), anatomical pattern, occurrence of retinal vasculitis (RV) and macular edema over time.ResultsRecords of 213 patients (341 eyes) were analyzed. No differences in complications were observed (p = 0.465). With regard to VA, a significant difference was detected in median BCVA (p = 0.046), which was not maintained after Bonferroni correction (p = 0.060). RV was significantly more prevalent in NIU-affected patients who tested positive for HLA-B51, irrespective of the systemic diagnosis of BD (p = 0.025). No differences emerged in the occurrence of macular edema (p = 0.99).ConclusionsPatients with NIU testing positive for HLA-B51 exhibit an increased likelihood of RV throughout disease course, irrespective of a systemic diagnosis of BD. The rate of complications as well as VA are comparable between NIU cases unrelated to BD testing positive for HLA-B51 and uveitis associated with BD. Therefore, it is advisable to perform the HLA-B typing in patients with NIU or retinal vasculitis, even in the absence of typical BD features.
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    The Systemic Score May Identify Life-Threatening Evolution in Still Disease: Data from the GIRRCS AOSD-Study Group and the AIDA Network Still Disease Registry
    Ruscitti, P; Masedu, F; Vitale, A; Caggiano, V; Di Cola, I; Cipriani, P; Valenti, M; Giardini, HAM; Antonelli, IPDB; Dagostin, MA; Lopalco, G; Iannone, F; Maria, M; Almaghlouth, IA; Asfina, KN; Ali, HH; Ciccia, F; Iacono, D; Pantano, I; Mauro, D; Sfikakis, PP; Tektonidou, M; Laskari, K; Berardicurti, O; Dagna, L; Tomelleri, A; Tufan, A; Kardas, RC; Hinojosa-Azaola, A; Martín-Nares, E; Kawakami-Campos, PA; Ragab, G; Hegazy, MT; Direskeneli, H; Alibaz-Oner, F; Fotis, L; Sfriso, P; Govoni, M; La Torre, F; Maggio, MC; Montecucco, C; De Stefano, L; Bugatti, S; Rossi, S; Makowska, J; Del Giudice, E; Emmi, G; Bartoloni, E; Hernández-Rodríguez, J; Conti, G; Olivieri, AN; Lo Gullo, A; Simonini, G; Viapiana, O; Wiesik-Szewczyk, E; Erten, S; Carubbi, F; De Paulis, A; Maier, A; Tharwat, S; Costi, S; Iagnocco, A; Sebastiani, GD; Gidaro, A; Brucato, AL; Karamanakos, A; Akkoç, N; Caso, F; Costa, L; Prete, M; Perosa, F; Atzeni, F; Guggino, G; Fabiani, C; Frediani, B; Giacomelli, R; Cantarini, L
    Objective. We aimed to evaluate the clinical usefulness of the systemic score in the prediction of life-threatening evolution in Still disease. We also aimed to assess the clinical relevance of each component of the systemic score in predicting life-threatening evolution and to derive patient subsets accordingly. Methods. A multicenter, observational, prospective study was designed including patients included in the Gruppo Italiano Di Ricerca in Reumatologia Clinica e Sperimentale Adult-Onset Still Disease Study Group and the Autoinflammatory Disease Alliance Network Still Disease Registry. Patients were assessed to see if the variables to derive the systemic score were available. The life-threatening evolution was defined as mortality, whatever the clinical course, and/or macrophage activation syndrome, a secondary hemophagocytic lymphohistiocytosis associated with a poor prognosis. Results. A total of 597 patients with Still disease were assessed (mean +/- SD age 36.6 +/- 17.3 years; male 44.4%). The systemic score, assessed as a continuous variable, significantly predicted the life-threatening evolution (odds ratio [OR] 1.24; 95% confidence interval [CI] 1.07-1.42; P = 0.004). A systemic score >= 7 also significantly predicted the likelihood of a patient experiencing life-threatening evolution (OR 3.36; 95% CI 1.81-6.25; P < 0.001). Assessing the clinical relevance of each component of the systemic score, liver involvement (OR 1.68; 95% CI 1.48-2.67; P = 0.031) and lung disease (OR 2.12; 95% CI 1.14-4.49; P = 0.042) both significantly predicted life-threatening evolution. The clinical characteristics of patients with liver involvement and lung disease were derived, highlighting their relevance in multiorgan disease manifestations. Conclusion. The clinical utility of the systemic score was shown in identifying Still disease at a higher risk of life-threatening evolution in a large cohort. Furthermore, the clinical relevance of liver involvement and lung disease was highlighted.
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    Development and implementation of the AIDA International Registry for patients with Behcet's disease
    Vitale, A; Della Casa, F; Ragab, G; Almaghlouth, IA; Lopalco, G; Pereira, RM; Guerriero, S; Govoni, M; Sfikakis, PP; Giacomelli, R; Ciccia, F; Monti, S; Ruscitti, P; Piga, M; Lomater, C; Tufan, A; Opris-Belinski, D; Emmi, G; Hernández-Rodríguez, J; Karkas, B; Sebastiani, GD; Bartoloni, E; Akkoç, N; Cattalini, M; Conti, G; Hatemi, G; Maier, A; Parronchi, P; Del Giudice, E; Erten, S; Insalaco, A; Li Gobbi, F; Maggio, MC; Shahram, F; Caggiano, V; Hegazy, MT; Asfina, KN; Morrone, M; Prado, LL; Dammacco, R; Ruffilli, F; Arida, A; Navarini, L; Pantano, I; Cavagna, L; Conforti, A; Cauli, A; Marucco, EM; Kucuk, H; Ionescu, R; Mattioli, I; Espinosa, G; Araújo, O; Canofari, C; Sota, J; Laymouna, AH; Bedaiwi, AA; Colella, S; Giardini, HAM; Albano, V; Lo Monaco, A; Fragoulis, GE; Kardas, RC; Berlengiero, V; Hussein, MA; Ricci, F; La Torre, F; Rigante, D; Wiesik-Szewczyk, E; Frassi, M; Gentileschi, S; Tosi, GM; Dagostin, MA; Mahmoud, AAMA; Tarsia, M; Alessio, G; Cimaz, R; Giani, T; Gaggiano, C; Iannone, F; Cipriani, P; Mourabi, M; Spedicato, V; Barneschi, S; Aragona, E; Balistreri, A; Frediani, B; Fabiani, C; Cantarini, L
    Purpose of the present paper is to point out the design, development and deployment of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to pediatric and adult patients with Behcet's disease (BD). The Registry is a clinical physician-driven non-population- and electronic-based instrument implemented for the retrospective and prospective collection of real-life data about demographics, clinical, therapeutic, laboratory, instrumental and socioeconomic information from BD patients; the Registry is based on the Research Electronic Data Capture (REDCap) tool, which is thought to collect standardised information for clinical real-life research, and has been realised to change over time according to future scientific acquisitions and potentially communicate with other existing and future Registries dedicated to BD. Starting from January 31st, 2021, to February 7th, 2022, 110 centres from 23 countries in 4 continents have been involved. Fifty-four of these have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 175 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry collects baseline and follow-up data using 5993 fields organised into 16 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access. The development of the AIDA International Registry for BD patients will facilitate the collection of standardised data leading to real-world evidence, enabling international multicentre collaborative research through data sharing, international consultation, dissemination of knowledge, inclusion of patients and families, and ultimately optimisation of scientific efforts and implementation of standardised care. Trial registration NCT05200715 in 21/01/2022.
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    A patient-driven registry on Behcet's disease: the AIDA for patients pilot project
    Gaggiano, C; Del Bianco, A; Sota, J; Gentileschi, S; Ruscitti, P; Giacomelli, R; Piga, M; Crisafulli, F; Monti, S; Emmi, G; De Paulis, A; Vitale, A; Tarsia, M; Caggiano, V; Nuzzolese, R; Parretti, V; Fabiani, C; Lopalco, G; Maier, A; Cattalini, M; Rigante, D; Govoni, M; Li Gobbi, F; Guiducci, S; Parronchi, P; Marino, A; Ciccia, F; Maggio, MC; Aragona, E; Bartoloni, E; Iagnocco, A; Viapiana, O; Sebastiani, GD; Guerriero, S; Insalaco, A; Del Giudice, E; Conti, G; Barone, P; Olivieri, AN; Brucato, A; Carubbi, F; Triggianese, P; Mauro, A; Tosi, GM; Fonollosa, A; Giardini, HAM; Ragab, G; Tharwat, S; Hernández-Rodríguez, J; Sfikakis, PP; Laskari, K; Karamanakos, A; Espinosa, G; Shahram, F; Direskeneli, H; Hinojosa-Azaola, A; Opris-Belinski, D; AlMaghlouth, IA; Hatemi, G; Eksin, MA; Önen, F; Wiesik-Szewczyk, E; Akkoç, N; Tufan, A; Sahin, A; Erten, S; Ozen, S; Batu, ED; Frediani, B; Balistreri, A; Cantarini, L
    IntroductionThis paper describes the creation and preliminary results of a patient-driven registry for the collection of patient-reported outcomes (PROs) and patient-reported experiences (PREs) in Behcet's disease (BD). MethodsThe project was coordinated by the University of Siena and the Italian patient advocacy organization SIMBA (Associazione Italiana Sindrome e Malattia di Behcet), in the context of the AIDA (AutoInflammatory Diseases Alliance) Network programme. Quality of life, fatigue, socioeconomic impact of the disease and therapeutic adherence were selected as core domains to include in the registry. ResultsRespondents were reached via SIMBA communication channels in 167 cases (83.5%) and the AIDA Network affiliated clinical centers in 33 cases (16.5%). The median value of the Behcet's Disease Quality of Life (BDQoL) score was 14 (IQR 11, range 0-30), indicating a medium quality of life, and the median Global Fatigue Index (GFI) was 38.7 (IQR 10.9, range 1-50), expressing a significant level of fatigue. The mean Beliefs about Medicines Questionnaire (BMQ) necessity-concern differential was 0.9 & PLUSMN; 1.1 (range - 1.8-4), showing that the registry participants prioritized necessity belief over concerns to a limited extent. As for the socioeconomic impact of BD, in 104 out of 187 cases (55.6%), patients had to pay from their own pocket for medical exams required to reach the diagnosis. The low family socioeconomic status (p < 0.001), the presence of any major organ involvement (p < 0.031), the presence of gastro-intestinal (p < 0.001), neurological (p = 0.012) and musculoskeletal (p = 0.022) symptoms, recurrent fever (p = 0.002), and headache (p < 0.001) were associated to a higher number of accesses to the healthcare system. Multiple linear regression showed that the BDQoL score could significantly predict the global socioeconomic impact of BD (F = 14.519, OR 1.162 [CI 0.557-1.766], p < 0.001). DiscussionPreliminary results from the AIDA for Patients BD registry were consistent with data available in the literature, confirming that PROs and PREs could be easily provided by the patient remotely to integrate physician-driven registries with complementary and reliable information.
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    Influence of gender on Behcet's disease phenotype and irreversible organ damage: Data from the International AIDA Network Behcet's Disease Registry
    Sota, J; Ragab, G; AlMaglouth, I; Lopalco, G; Tufan, A; Direskeneli, H; Hinojosa-Azaola, A; Giardini, HAM; Guerriero, S; Triggianese, P; Sfikakis, PP; Piga, M; Ruscitti, P; Govoni, M; Iagnocco, A; Carubbi, F; Hernández-Rodríguez, J; Laymouna, AH; Mahmoud, AAMA; Ghanema, M; Aboabat, AA; Asfina, KN; Alanazi, F; Morrone, M; Spedicato, V; Kucuk, H; Kardas, R; Öner, FA; Sevik, G; Torres-Ruiz, J; Kawakami-Campos, PA; Antonelli, IPDB; Dammacco, R; Chimenti, MS; Arida, K; Floris, A; Gentile, M; Ruffilli, F; Bellis, E; Alunno, A; Espinosa, G; Gentileschi, S; Gaggiano, C; Vitale, A; Caggiano, V; Lopez, R; Tarsia, M; Montis, S; Hatemi, G; Karakoc, A; Frassi, M; Giacomelli, R; Tharwat, S; Thabet, M; Ciccia, F; Emmi, G; Viapiana, O; Sahin, A; Sebastiani, GD; Batu, ED; Ozen, S; Sener, S; Opris-Belinski, D; Costi, S; Conforti, A; Cattalini, M; Bartoloni, E; Akkoç, N; Gunduz, OS; Conti, G; Maier, A; Giardina, A; Li Gobbi, F; Parronchi, P; Puttini, PS; Breda, L; De Paulis, A; Carreño, E; La Torre, F; Wiesik-Scewczyk, E; de-la Torre, A; Mejía-Salgado, G; Shahram, F; Guiducci, S; Maggio, MC; Aragona, E; Rigante, D; Ciavarro, A; Önen, F; Erten, U; Insalaco, A; Del Giudice, E; Barone, P; Gicchino, F; Brucato, A; Lo Gullo, A; Mauro, A; Karamanakos, A; Balistreri, A; Mazzei, MA; Frediani, B; Fabiani, C; Cantarini, L
    Objectives. - Gender impact on phenotypical expression of Behcet's disease (BD) has been specifically investigated only in a few large-scale studies. The main goal of the study was to examine gender differences in a large cohort of patients affected by BD. Methods. - Data were retrieved from the International AIDA Network Registry for BD. We assessed differences between males and females in terms of Behcet's syndrome Overall Damage Index (BODI), differences in the disease manifestations at onset and in the cumulative manifestations throughout diseasecourse, as well as differences in the cardiovascular risk. Finally, predictive factors leading to major organ involvement were investigated. Results. - In total, 1024 BD patients (567 males, 457 females) were enrolled in the study, with a male-to-female ratio of 1.24/1. Males displayed a significantly higher mean +/- SD BODI (1.92 +/- 2.09) at the last follow-up, compared to female patients (1.25 +/- 1.87) (P < 0.0001). Uveitis (P < 0.0001) and vascular involvement (P = 0.0076) were significantly more frequent among males whereas female patients were significantly over-represented in arthralgia (P < 0.0001), arthritis (P = 0.00025), isolated headache (P < 0.0001), central nervous system (CNS) involvement (P = 0.040), and gastrointestinal involvement (P = 0.00046). Regarding cardiovascular risk, no differences between the two groups emerged (P = 0.617). Four variables were associated with the development of major organ involvement: male gender (OR = 2.104, P = 0.001), current treatment with biologic agents (OR = 2.257, P = 0.0003), origin from endemic countries (OR = 2.661, P = 0.0009), and disease duration (OR = 1.002, P = 0.024). Conclusion. - BD displays a more severe course among males. This subgroup develops more irreversible damage and presents more frequently ocular and vascular involvement during disease course. On the other hand, female patients are prone to experience articular involvement, headache, CNS and gastrointestinal involvement. These data suggest the existence of a gender-driven disease expression. (c) 2024 Les Auteurs. Publie par Elsevier Masson SAS au nom de Socioto Franoaise de Rhumatologie. Cet article est publie en Open Access sous licence CC BY (http://creativecommons.org/licenses/by/4.0/).
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    A real-life analysis of patients with rheumatologic diseases on biological treatments: Data from TURKBIO Registry
    Önen, 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, N
    Objective: 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.
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    Biological treatment in elderly and young patients with ankylosing spondylitis: TURKBIO real-life data results
    Uslu, 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, F
    Objectives: 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.
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    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 Registry
    Uslu, 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, F
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    The impact of smoking on response to tumor necrosis factor-α inhibitor treatment in patients with ankylosing spondylitis
    Tugsal, 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, F
    Background/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.
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    Body mass index does not affect response of rituximab in patients with rheumatoid arthritis: results from the TURKBİO registry
    Karatas, 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, F
    Background/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.
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    Prevalence of Spondyloarthritis Among Patients Who Underwent Lumbar Disc Herniation Surgery
    Gündüz, OS; Akar, S; Solmaz, D; Can, G; Önen, F; Akkoç, N
    Objectives: This study aims to estimate the prevalence of spondyloarthritis (SpA) among patients who had been surgically treated for lumbar disc herniation (LDH), according to the modified New York (mNY) criteria for the diagnosis of ankylosing spondylitis and Amor, the European Spondyloarthropathy Study Group (ESSG), the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for SpA. Patients and methods: The study included 321 patients (142 males, 179 females; mean age 49 +/- 10.8 years; range, 18 to 79 years) who underwent LDH surgery between April 2008 and May 2012 in the neurosurgery clinic of our hospital. Patients were contacted by phone on at least two attempts. Totally, 123 patients accepted to come to the outpatient clinic, while the remaining 198 agreed to be interviewed on the phone. Patients who agreed to come to the outpatient rheumatology clinic underwent clinical examination, and pelvic X-ray and magnetic resonance imaging (MRI) scan of the sacroiliac joints when indicated. Results: Inflammatory back pain was diagnosed in 108 patients (34%) and 40 patients (13%) according to Calin criteria and the ASAS criteria, respectively. Prevalence of SpA among all patients was estimated as 17.7% according to the ESSG criteria, and 8.7% according to Amor criteria. Five of the 308 pelvic radiographs had definite radiographic sacroiliitis as required by the mNY criteria. Four patients had a characteristic pattern of bone marrow edema on MRI examination in accordance with the ASAS definitions. The overall prevalence of sacroiliitis (MRI sacroiliitis+X-ray sacroiliitis) among the patients who came to the clinic was 7.3% ([4+5]/123). Conclusion: The relatively increased prevalence of SpA among patients who underwent LDH surgery indicates the necessity of increasing awareness on the new concept of axial SpA for specialists treating patients with low back pain.
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    Predicting ASDAS Inactive Disease After 6 Months of TNFi Treatment in Bio-Naive Axial Spondyloarthritis Patients Treated in Clinical Practice - Results from the EuroSpA Collaboration
    Ornbjerg, LM; Georgiadis, S; Lindström, U; Loft, AG; Ciurea, A; Mann, H; Akkoç, N; Iannone, F; Kristianslund, E; Hokkanen, AM; Santos, MJ; Codreanu, C; Sánchez-Piedra, C; Tomsic, M; Gudbjornsson, B; van der Horst-Bruinsma, I; Askling, J; Nissen, MJ; Pavelka, K; Gunduz, O; Atzeni, F; Sexton, J; Nordström, D; Santos, H; Ionescu, R; Pombo-Suarez, M; Rotar, Z; Geirsson, AJ; van de Sande, M; Macfarlane, G; Michelsen, B; Hetland, ML; Ostergaard, M
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    Development of a Set of ASAS Quality Standards for Adults with Axial Spondyloarthritis
    Kiltz, U; Landewé, RBM; van der Heijde, D; Rudwaleit, M; Weisman, M; Akkoç, N; Boonen, A; Brandt-Jürgens, J; Carron, P; Dougados, M; Gossec, L; Jongkees, M; Machado, P; Marzo-Ortega, H; Molto, A; Navarro-Compán, V; Niedermann-Schneider, K; Sampaio-Barros, PD; Slobodin, G; Van den Bosch, F; van Tubergen, A; van Weely, S; Wiek, D; Braun, J
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    Impact of rheumatoid arthritis in Turkey: a questionnaire study
    Direskeneli, 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, E
    Objective 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.