Browsing by Author "Senel, S"
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Item The Efficacy and Safety of CT-P13 as First-line and Subsequent-line Therapy in Patients with Ankylosing Spondylitis: Real-life Data from TURKBIO CohortUslu, S; Gulle, S; Can, G; Senel, S; Capar, S; Dalkilic, HE; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanc, N; Birlik, M; Solmaz, D; Cefle, A; Goker, B; Yolbas, S; Krough, NS; Yilmaz, N; Erten, S; Bes, C; Soysal, O; Ozturk, MA; Haznedaroglu, S; Yavuz, S; Direskeneli, H; Onen, F; Sari, IItem Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing SpondylitisUslu, S; Gülle, S; Sen, G; Capar, S; Senel, S; Dalkilic, E; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanc, N; Birlik, M; Solmaz, D; Cefle, A; Goker, B; Direskeneli, H; Yolbas, S; Krogh, NS; Yilmaz, N; Erten, S; Bes, C; Gündüz, OS; Oztürk, MA; Haznedaroglu, S; Yavuz, S; Onen, F; Sari, IBackground/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 na & iuml;ve (1st-line) and subsequently treated (>= 2nd-line) with CT-P13 showed encouraging drug retention rates with acceptable long-term effectiveness and safety.Item Assessing safety and efficacy of TNFi treatment in late onset ankylosing spondylitis: a TURKBIO registry studyUslu, S; Gulle, S; Sen, G; Cefle, A; Yilmaz, S; Kocaer, SB; Inel, TY; Koca, SS; Yolbas, S; Ozturk, MA; Senel, S; Inanc, N; Dalkilic, HE; Gunduz, OS; Tufan, A; Akar, S; Birlik, AM; Sari, I; Akkoc, N; Onen, FClinical 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.Item Efficacy and Safety of Secukinumab in the Treatment of Axial Spondyloarthritis: Real-Life Data from TURKBIO CohortGulle, S; Karakas, A; Can, G; Senel, S; Capar, S; Dalkilic, HE; Akar, S; Koca, SS; Tufan, A; Yazici, A; Yilmaz, S; Inanc, N; Birlik, M; Solmaz, D; Cefle, A; Goker, B; Yolbas, S; Krough, NS; Yilmaz, N; Erten, S; Bes, C; Soysal, O; Ozturk, MA; Haznedaroglu, S; Yavuz, S; Direskeneli, H; Onen, F; Sari, IItem 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 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 DISEASE DURATION AND HLA-B27 POSITIVITY ALTER LONGTERM RETENTION RATE OF CERTOLIZUMAB PEGOL IN PATIENTS WITH PSORIATIC ARTHRITISKoca, SS; Pehlivan, Y; Akar, S; Senel, S; Karadeniz, H; Sosyal, O; Yazici, A; Yilmaz, S; Sagir, RP; Inanc, N; Karatas, A; Cetin, GY; 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 LONGTERM RETENTION RATE OF CERTOLIZUMAB PEGOL IN AXIAL SPONDYLOARTHRITIS IS HIGHER: DATA FROM TURKBIOKoca, SS; Pehlivan, Y; Akar, S; Senel, S; Guler, AA; Sosyal, O; Yazici, A; Yilmaz, S; Sagir, RP; Inanc, N; Karatas, A; Cetin, GY; Atagündüz, P; Onen, FItem 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 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 Does obesity affect treatment response to secukinumab and survival in ankylosing spondylitis? Real-life data from the TURKBIO RegistryKarakas, A; Gulle, S; Can, G; Dalkilic, E; Akar, S; Koca, SS; Pehlivan, Y; Senel, S; Tufan, A; Ozturk, MA; Yilmaz, S; Yazici, A; Cefle, A; Inel, TY; Erez, Y; Sari, I; Birlik, M; Direskeneli, H; Akkoc, N; Onen, FObjectives 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/m(2)], overweight (BMI: 25-30 kg/m(2)), and obese (BMI & GE; 30 kg/m(2)). 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 & PLUSMN; 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.Item 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.Item Is there a role for TNF-α antagonists in the treatment of SSc? EUSTAR expert consensus development using the Delphi techniqueDistler, JHW; Jordan, S; Airò, P; Alegre-Sancho, JJ; Allanore, Y; Gurman, AB; Caporali, R; Caramaschi, P; Carreira, PE; Chizzolini, C; Cutolo, M; Duruöz, MT; Farge-Bancel, D; Hesselstrand, R; Iannone, F; De Keyser, F; Kucharz, EJ; Launay, D; Lefebvre, PGD; Lukacova, O; Marasini, B; Martinovic, D; Neto, JFM; Radic, M; Rednic, S; Riemekasten, G; Rovensky, J; Seidel, MF; Senel, S; Smith, V; Sunderkötter, C; Ton, E; van Laar, JM; Matucci-Cerinic, M; Müller-Ladner, U; Distler, OObjective: To obtain experiences and expert opinion on treatment of SSc patients with TNF-alpha antagonists. Methods: An investigation was carried out among the EUSTAR centres into their expertise on use of TNF-alpha antagonists. Assessment forms on the frequency of TNF-alpha 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-alpha inhibitors in SSc. Results: Seventy-nine centres returned information on use of TNF-alpha antagonists in SSc patients. A total of 65 patients were treated with TNF-alpha inhibitors in 14 different centres. Forty-eight of the 65 patients treated with TNF-alpha 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-alpha antagonists in SSc. Arthritis was suggested as an indication for TNF alpha antagonists by 75% of the experts. However; after the third stage of the Delphi exercise, the acceptance for the off-label use of TNF-alpha antagonists decreased and 59% recommended that TNF-alpha antagonists should not be used or only used in clinical trials in SSc patients, while 38% of the experts suggested the use of TNF-alpha antagonists for arthritis associated with SSc. Conclusions: Most of the experts do not recommend the routine use of TNF-alpha antagonists in systemic sclerosis. Arthritis might be a potential indication in SSc, although controlled clinical trials with TNF-alpha antagonists are needed before general recommendations can be given.