Browsing by Author "Senel S."
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Item Is there a role for TNF-α antagonists in the treatment of SSc? EUSTAR expert consensus development using the Delphi technique(2011) Distler J.H.W.; Jordan S.; Airò P.; Alegre-Sancho J.J.; Allanore Y.; Balbir Gurman A.; Caporali R.; Caramaschi P.; Carreira P.E.; Chizzolini C.; Cutolo M.; Tuncay Duruöz M.; Farge-Bancel D.; Hesselstrand R.; Iannone F.; De Keyser F.; Kucharz E.J.; Launay D.; García De La Peña Lefebvre P.; Lukacova O.; Marasini B.; Martinovic D.; Marques Neto J.F.; Radic M.; Rednic S.; Riemekasten G.; Rovensky J.; Seidel M.F.; Senel S.; Smith V.; Sunderkötter C.; Ton E.; Van Laar J.M.; Matucci-Cerinic M.; Müller-Ladner U.; Distler O.Objective: To obtain experiences and expert opinion on treatment of SSc patients with TNF-α antagonists. Methods: An investigation was carried out among the EUSTAR centres into their expertise on use of TNF-α antagonists. Assessment forms on the frequency of TNF-α inhibitor use were distributed to EULAR Scleroderma Trials and Research Group (EUSTAR) centres. Afterwards, a three round Delphi exercise was performed to obtain expert consensus on the use of TNF-α inhibitors in SSc. Results: Seventy-nine centres returned information on use of TNF-α antagonists in SSc patients. A total of 65 patients were treated with TNF-a inhibitors in 14 different centres. Forty-eight of the 65 patients treated with TNF-α inhibitors improved. Improvement was mainly seen in patients with arthritis, whereas the effects on fibrosis varied. In the first round of the subsequent Delphi approach, 71 out of 79 experts stated that they would use TNF-α antagonists in SSc. Arthritis was suggested as an indication for TNFa antagonists by 75% of the experts. However, after the third stage of the Delphi exercise, the acceptance for the off-label use of TNF-a antagonists decreased and 59% recommended that TNF-α antagonists should not be used or only used in clinical trials in SSc patients, while 38% of the experts suggested the use of TNF-a antagonists for arthritis associated with SSc. Conclusions: Most of the experts do not recommend the routine use of TNF-a antagonists in systemic sclerosis. Arthritis might be a potential indication in SSc, although controlled clinical trials with TNF-α antagonists are needed before general recommendations can be given. © Copyright Clinical and Experimental Rheumatology 2011.Item Assessing safety and efficacy of TNFi treatment in late onset ankylosing spondylitis: a TURKBIO registry study(Nature Research, 2024) Uslu S.; Gulle S.; Sen G.; Cefle A.; Yilmaz S.; Kocaer S.B.; Yuce Inel T.; Koca S.S.; Yolbas S.; Ozturk M.A.; Senel S.; Inanc N.; Dalkilic H.E.; Soysal Gunduz O.; Tufan A.; Akar S.; Birlik A.M.; Sari I.; Akkoc N.; Onen F.Clinical data on the use of tumour necrosis factor inhibitors (TNFi) in late-onset ankylosing spondylitis (LoAS) are limited. The present study aimed to evaluate efficacy, safety, and treatment adherence associated with the initial use of TNFi therapy in biologic naive patients diagnosed with LoAS. Patients whose age of onset was ≥ 45 years and < 45 years were classified as having LoAS and YoAS, respectively, based on the age of symptom onset. There were 2573 patients with YoAS and 281 LoAS. Baseline disease activity measures were similar between the groups. No significant differences were seen between the two groups in response to treatment and in remaining on the first TNFi at 6, 12 and 24 months. In the LoAS group, the analysis showed that TNFi discontinuation was linked to VAS pain score (HR 1.04; 95% CI 1.01–1.06). Patient groups had similar rates of adverse events (YoAS: 8.7% vs. LoAS: 11.7%). In both biologic naive LoAS and YoAS patients, the study showed that the initial TNFi therapy was equally effective and safe. © The Author(s) 2024.Item Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis(Multidisciplinary Digital Publishing Institute (MDPI), 2024) Uslu S.; Gülle S.; Sen G.; Capar S.; Senel S.; Dalkılıc E.; Akar S.; Koca S.S.; Tufan A.; Yazici A.; Yilmaz S.; Inanc N.; Birlik M.; Solmaz D.; Cefle A.; Goker B.; Direskeneli H.; Yolbas S.; Steen Krogh N.; Yilmaz N.; Erten S.; Bes C.; Soysal Gündüz O.; Oztürk M.A.; Haznedaroglu S.; Yavuz S.; Onen F.; Sari I.Background/Objectives: CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in patients with AS undergoing first-line (1st-line) and later (≥2nd-line) treatment in clinical practice. Methods: We performed an observational cohort study that included AS patients based on the biological drug database in the TURKBIO Registry between 2014 and 2021. The patients were divided into two groups: those receiving CT-P13 as first-line treatment or as a switch (≥2nd-line) from another TNF inhibitor (TNFi). Standard disease activity metrics were used to assess the effectiveness of CT-P13, and drug retention rates were investigated. Results: There were 179 AS patients using CT-P13 (47.4% male, mean age: 42.9 ± 11.3 years). Of these patients, 123 (68.7%) were receiving CT-P13 as a first-line treatment. The mean length of treatment was 3.5 years. CT-P13 drug retention rates in the general patient population were 58.6% and 48.2% in the first-line and ≥second-line treatment, respectively, after 3 years of follow-up. The most common reason for CT-P13 treatment discontinuation was lack of efficacy. The first-line CT-P13 group had statistically substantially higher ASAS20/40 response rates at three and six months. Nonetheless, both groups’ response rates at one year were comparable. Conclusions: In this real-world data analysis, AS patients who were TNFi naïve (1st-line) and subsequently treated (≥2nd-line) with CT-P13 showed encouraging drug retention rates with acceptable long-term effectiveness and safety. © 2024 by the authors.Item Does obesity affect treatment response to secukinumab and survival in ankylosing spondylitis? Real-life data from the TURKBIO Registry(Oxford University Press, 2024) Karakaş A.; Gulle S.; Can G.; Dalklllc E.; Akar S.; Koca S.S.; Pehlivan Y.; Senel S.; Tufan A.; Ozturk M.A.; Yilmaz S.; Yazici A.; Cefle A.; Yüce Inel T.; Erez Y.; Sari I.; Birlik M.; Direskeneli H.; Akkoc N.; Onen F.Objectives: The aim of this study was to evaluate the impact of obesity on the treatment response to secukinumab and drug survival rate in patients with ankylosing spondylitis (AS). Methods: We performed an observational cohort study that included AS patients based on the biological drug database in Turkey (TURKBIO) Registry between 2018 and 2021. The patients were divided into three groups: normal [body mass index (BMI) < 25 kg/m2], overweight (BMI: 25-30 kg/m2), and obese (BMI ≥ 30 kg/m2). Disease activity was evaluated at baseline, 3, 6, and 12 months. Drug retention rates at 12 months were also investigated. Results: There were 166 AS patients using secukinumab (56.6% male, mean age: 44.9 ± 11.6 years). The median follow-up time was 17.2 (3-33.2) months. Forty-eight (28.9%) patients were obese. The mean age was higher in the obese group than in others (P =. 003). There was no statistically significant difference in Bath Ankylosing Spondylitis Disease Activity Index 50, Assessment of SpondyloArthritis international Society 20 (ASAS20), ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity, and ASDAS clinically important improvement responses between the three groups at 3, 6, and 12 months, although they were numerically lower in obese patients. Drug retention rates at 12 months were similar in all groups (P >. 05). Conclusions: This study suggested that obesity did not affect secukinumab treatment response and drug retention in AS patients. © 2023 Japan College of Rheumatology. Published by Oxford University Press. All rights reserved.