21 results on '"E. Saracbasi"'
Search Results
2. SAT0135 COMPARISON OF THE EFFICACY AND SAFETY OF TWO BRIDGING SCHEDULES OF PREDNISOLONE IN EARLY ACTIVE RHEUMATOID ARTHRITIS (CORRA): A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED TRIAL
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Nina Timmesfeld, Hans J. Trampisch, C. Fendler, M. Igelmann, J. Christoph, A. Mai, J. Braun, A. Schmid, S. Boeddeker, Ulrike Trampisch, Dietmar Krause, Xenofon Baraliakos, E. Schmitz, Henrik Rudolf, H.-J. Menne, E. Saracbasi, Renate Klaassen-Mielke, and C. Klink
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medicine.medical_specialty ,business.industry ,Immunology ,Placebo-controlled study ,Schering-Plough ,medicine.disease ,Placebo ,Placebo group ,General Biochemistry, Genetics and Molecular Biology ,Double blind ,Regimen ,Rheumatology ,Rheumatoid arthritis ,Internal medicine ,medicine ,Prednisolone ,Immunology and Allergy ,business ,medicine.drug - Abstract
Background:Rheumatoid arthritis (RA) is a chronic inflammatory joint disease potentially leading to disability, impaired functioning, and premature death. Most treatment strategies include the early use of disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX) which is considered as an established ‘anchor’ therapy. Since it takes some weeks until MTX shows clinical efficacy, glucocorticoids (GC) are widely used for bridging.Objectives:The aim of the study “Comparison of the efficacy and safety of two starting dosages of prednisolone in early active RA” (CORRA) is to compare the efficacy and safety of two standard GC bridging schedules vs. placebo in addition to MTX, following a treat-to-target regimen, in early RA.Methods:CORRA is an investigator-initiated, randomised, multi-center, double-blind, placebo-controlled trial. Adult RA patients who were eligible for inclusion in the trial if they had a disease duration of less than 3 years and moderate or high disease activity were recruited in one hospital and 18 rheumatology practices in Germany. Patients were randomised (1:1:1) to receive 60 mg or 10 mg prednisolone (Pred) orally once daily (tapered down to 5 mg Pred within 8 weeks) or placebo. The duration of the intervention was 12 weeks, followed by an open observational phase for another 40 weeks. All patients were also treated with MTX (usually starting with 15mg/week followed by a treat-to target scheme). The primary efficacy endpoint was the progression of the radiographic joint damage after one year compared to baseline as determined by the van der Heijde modification of the Sharp score (SHS). Patients, physicians and readers of radiographs were unaware of the treatment assignments. For the comparison of the two GC groups, a non-inferiority margin of 1.3 points of the SHS was set. This trial was registered at ClinicalTrials.gov, numberNCT02000336.Results:Between February 2014 and February 2017, 395 patients were included in the trial, 381 of which had sufficient data also of follow-up visits. A total of 129 patients were assigned to the 60 mg Pred group, 124 to 10 mg Pred and 128 to the placebo group. At baseline, mean age was 58 years, 58% were female, 55% were rheumatoid factor and 52% ACPA positive. The mean number of swollen joints was 12.8 out of 28, mean ESR was 33.6 mm/h, mean CRP 2.2 mg/dL, mean DAS 28 6.0. Radiographic damage was 4.9 as measured by the SHS. In the 60 mg, 10 mg Pred group and in the placebo group, the DAS 28 was 2.6, 3.1, 4.5 at week 4 (pConclusion:The bridging schedule starting with 60 mg Pred reduced disease activity better than the 10 mg schedule or placebo only for a short time. The primary outcome structural damage was non-inferior in the 10 mg Pred and the placebo group in comparison to the 60 mg Pred group. Initial advantages of the higher dose may have been compromised by the long follow-up with the possible escalation of therapy due to the treat-to-target regimen.Disclosure of Interests:Dietmar Krause Grant/research support from: Pfizer and AbbVie (Abbott), Anna Mai: None declared, Nina Timmesfeld: None declared, Ulrike Trampisch: None declared, Renate Klaassen-Mielke: None declared, Henrik Rudolf: None declared, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Elmar Schmitz: None declared, Claas Fendler: None declared, Claudia Klink: None declared, Stephanie Boeddeker: None declared, Ertan Saracbasi: None declared, Jochen Christoph: None declared, Manfred Igelmann: None declared, Hans Juergen Menne: None declared, Albert Schmid: None declared, Hans J Trampisch: None declared, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma
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- 2020
3. Praktische Probleme bei der Umsetzung von Impfempfehlungen
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Frank Heldmann, C. Fendler, F. Dybowski, J. Braun, and E. Saracbasi
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Gynecology ,medicine.medical_specialty ,Rheumatology ,business.industry ,Medicine ,Interdisciplinary communication ,Cooperative behavior ,business ,Patient compliance - Abstract
Patienten mit entzundlich-rheumatischen Erkrankungen haben durch die Grunderkrankung sowie durch die haufig fur die Behandlung erforderlichen Immunsuppressiva ein erhohtes Infektrisiko. Zu den wichtigsten infektionsprophylaktischen Masnahmen zahlen Impfungen, zumal diese heute nur noch sehr selten gravierende Nebenwirkungen haben. Aus diesem Grund hat die Standige Impfkommission (STIKO) im Jahr 2005 Empfehlungen fur Patienten mit Immundefizienz veroffentlicht. Die Deutsche Gesellschaft fur Rheumatologie (DGRh) hat diese Empfehlungen fur Patienten mit entzundlich-rheumatischen Erkrankungen ubernommen und prazisiert. Da neue in der Rheumatologie zunehmend eingesetzte Medikamente die Impfantwort beeinflussen konnen, ist der Impfstatus ein wichtiges Thema in der taglichen Versorgung geworden. Daten zur Umsetzung von Impfempfehlungen bei Patienten mit entzundlich-rheumatischen Erkrankungen fehlen fast vollig.
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- 2012
4. Generalisierte Arthrose im jungen Erwachsenenalter bei Typ-II-Kollagenopathie
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Jürgen Braun, F. Dybowski, Frank Heldmann, F Moos, and E. Saracbasi-Zender
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musculoskeletal diseases ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Physical examination ,General Medicine ,Disease ,Osteoarthritis ,medicine.disease ,Surgery ,Lumbar ,Internal medicine ,Rheumatoid arthritis ,Radiological weapon ,medicine ,Methotrexate ,Young adult ,business ,medicine.drug - Abstract
History and admission findings In the 20-year-old patient increasing arthralgia since the age of seven years had caused functional impairment. As seronegative osteodestructive rheumatoid arthritis had been suspected, he was treated with methotrexate and steorid for ovemore than one year, without success.r Investigations The clinical examination revealed a compromised function of the knee and hip joints. Conventional radiographs showed severe degenerative changes in these regions. The radiographs of the lumbar and the thoracic spine were suggestive of osteoporotic fractures. Diagnosis, treatment and course The clinical and radiological findings led to the suspicion of a hereditary collagenous disease. Genetic analyses revealed a COL2A1 mutation. The treatment included analgesics, non-steroidal antirheumatic drugs, opiates and regular physiotherapy to build up and maintain muscle strength. Conclusion In young adult patients with osteoarthritis mutations in the COL2A1 gene should considered. This mutation with the substitution pArg75Cys should be in focus because of the phenotypes in clinical manifestations.
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- 2011
5. Identifying patients with axial spondyloarthritis in primary care: how useful are items indicative of inflammatory back pain?
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E. Saracbasi, Joachim Grifka, J Braun, A. Braun, and J Schnitker
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Adult ,Male ,medicine.medical_specialty ,Referral ,Adolescent ,Immunology ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Diagnosis, Differential ,Young Adult ,Age Distribution ,Rheumatology ,Randomized controlled trial ,law ,Spondylarthritis ,medicine ,Back pain ,Immunology and Allergy ,Humans ,Spondylitis, Ankylosing ,Age of Onset ,Spondylitis ,Referral and Consultation ,Axis, Cervical Vertebra ,HLA-B27 Antigen ,Ankylosing spondylitis ,HLA-B27 ,Primary Health Care ,business.industry ,Patient Selection ,Anti-Inflammatory Agents, Non-Steroidal ,Buttock Pain ,Clinical and Epidemiological Research ,medicine.disease ,Early Diagnosis ,Back Pain ,Chronic Disease ,Physical therapy ,Female ,Age of onset ,medicine.symptom ,business ,Epidemiologic Methods - Abstract
BackgroundThe value of clinical items defining inflammatory back pain to identify patients with axial spondyloarthritis (SpA) in primary care is unclear.ObjectiveTo identify predictive clinical parameters for a diagnosis of axial SpA in patients with chronic back pain presenting in primary care.MethodsConsecutive patients aged 2 months who presented to orthopaedic surgeons (n=143) were randomised based on four key questions for referral to rheumatologists (n=36) for diagnosis.ResultsThe rheumatologists saw 322 representative patients (mean age 36 years, 50% female, median duration of back pain 30 months). 113 patients (35%) were diagnosed as axial SpA (62% HLA B27+), 47 (15%) as ankylosing spondylitis (AS) and 66 (21%) as axial non-radiographic SpA (nrSpA). Age at onset ≤35 years, improvement by exercise, improvement with non-steroidal anti-inflammatory drugs, waking up in the second half of the night and alternating buttock pain were identified as most relevant for diagnosing axial SpA by multiple regression analysis. Differences between AS and nrSpA were detected. No single item was predictive, but ≥3 items proved useful for good sensitivity and specificity by receiver operating characteristic modelling.ConclusionThis study shows that a preselection in primary care of patients with back pain based on a combination of clinical items is useful to facilitate the diagnosis of axial SpA.
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- 2011
6. [Practical problems by implementation of vaccination recommendations]
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C, Fendler, E, Saracbasi, F, Dybowski, F, Heldmann, and J, Braun
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Male ,Biological Products ,Immunization Programs ,Middle Aged ,Medical Records ,Methotrexate ,Patient Admission ,Antirheumatic Agents ,Germany ,Rheumatic Diseases ,Antibody Formation ,Humans ,Patient Compliance ,Female ,Interdisciplinary Communication ,Cooperative Behavior ,Glucocorticoids ,Immunization Schedule ,Immunosuppressive Agents - Abstract
Patients with inflammatory rheumatic diseases are known to have an increased risk of infections due to the rheumatic disease itself and due to therapy with immunosuppressive agents. The most important procedure to prevent infections is vaccinations, which are usually well-tolerated. The German National Commission for Immunization ( STIKO) has published recommendations for patients with an immunodeficiency. The German Society of Rheumatology (DGRh) has generally implemented these recommendations for patients with chronic inflammatory rheumatic diseases. The immunization status of patients with rheumatic diseases is of increasing importance in routine patient care because some of the recently approved drugs may influence the strength of the immune response to vaccination. However, there is almost no information about the current immunization status and the willingness of patients with rheumatic diseases to undergo vaccination procedures in Germany. There are also no epidemiologic data on the implementation of recommendations for immunization at the level of general practitioners. Here we present the results of a prospective study on the efficacy of standardized recommendations for immunization given to different patient groups with rheumatic diseases treated in a hospital specialized in rheumatology.
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- 2012
7. [Generalized osteoarthritis in a young adult with type II collagenopathy]
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F, Dybowski, F, Moos, E, Saracbasi-Zender, F, Heldmann, and J, Braun
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Male ,Lumbar Vertebrae ,Age Factors ,Osteoarthritis, Knee ,Osteochondrodysplasias ,Osteoarthritis, Hip ,Thoracic Vertebrae ,Diagnosis, Differential ,Radiography ,Young Adult ,Osteoarthritis ,Humans ,Osteoarthritis, Spine ,Collagen Type II ,Osteoporotic Fractures - Abstract
In the 20-year-old patient increasing arthralgia since the age of seven years had caused functional impairment. As seronegative osteodestructive rheumatoid arthritis had been suspected, he was treated with methotrexate and steorid for ovemore than one year, without success.rThe clinical examination revealed a compromised function of the knee and hip joints. Conventional radiographs showed severe degenerative changes in these regions. The radiographs of the lumbar and the thoracic spine were suggestive of osteoporotic fractures.The clinical and radiological findings led to the suspicion of a hereditary collagenous disease. Genetic analyses revealed a COL2A1 mutation. The treatment included analgesics, non-steroidal antirheumatic drugs, opiates and regular physiotherapy to build up and maintain muscle strength.In young adult patients with osteoarthritis mutations in the COL2A1 gene should considered. This mutation with the substitution pArg75Cys should be in focus because of the phenotypes in clinical manifestations.
- Published
- 2011
8. OP0038 Patients with Fibromyalgia (FM) do not Fulfill Classification Criteria for Axial Spondyloarthritis (AXSPA) but Patients with Axspa May Fulfill Classification Criteria for FM
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Dietmar Krause, Andrea Regel, Ludwig Kalthoff, J. Braun, H.-J. Menne, Uta Kiltz, E. Saracbasi, D. Kiefer, X. Baraliakos, Friedrich Dybowski, M. Igelmann, and E. Schmitz-Bortz
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HLA-B27 ,medicine.medical_specialty ,business.industry ,Immunology ,Mean age ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Outcome parameter ,Rheumatology ,Fibromyalgia ,Rheumatoid arthritis ,Physical therapy ,medicine ,Immunology and Allergy ,Axial spondyloarthritis ,Overdiagnosis ,business ,Prospective cohort study - Abstract
Background Both patients with axial spondyloarthritis (axSpA) and patients with fibromyalgia (FM) are suffering from pain. The new ASAS classification criteria for axSpA have been recently challenged by arguing that FM patients could easily fulfill the clinical arm of the criteria, which could lead to overdiagnosis of axSpA and wrong treatment decisions. Objectives To study similarities and differences between axSpA and FM using different sets of classification criteria and to assess the severity of wide-spread pain in both diseases. Methods In this prospective study, patients were consecutively included if they were diagnosed with axSpA, or FM by a rheumatologist. Patients with rheumatoid arthritis (RA) were also included as an inflammatory control group. Patients on anti-TNF treatment were not included. Established classification and outcome parameters as well as standardized instruments were used in all patients. MRIs were performed in all axSpA and 20 FM patients. All axSpA and FM patients had radiographs. The Mann-Whitney-U test was used for statistical comparisons between groups. Results A total of 214 patients was included: 93 with FM (7.5% HLA B27+), 91 with axSpA (79.1% HLA-B27+) and 30 with RA (53.3% seropositive). The mean age was 50.7±9.1, 43.0±12 and 58.4±11.9 years, respectively, and the mean symptom duration was comparable between groups: 6.6±6.9, 6.4±7.8 and 6.2±11.3, respectively. Expectedly, the gender ratio differed: FM and RA patients were mostly female (93.4% and 76.7%, respectively), as compared to axSpA patients (28.3%). The ASAS classification criteria were not fulfilled by any FM patient. In contrast, the 1990 and 2010 FM criteria were fulfilled by 98.3% and 100% of patients with FM, but also by 14.3% and 34.1% of axSpA (no differences between AS and nr-axSpA) and 30% and 46.7% of RA patients, respectively. The Fibromyalgia impact questionnaire (FIQ) values were 69.5±13.0, 45.4±19.3 (p Conclusions Importantly, no FM patients fulfilled ASAS classification criteria. Only a small proportion of patients with axSpA fulfilled any of the FM classification criteria. There was less overlap between patients with FM, axSpA and RA using the 1990 criteria as compared to the more sophisticated 2010 FM criteria. FM patients reported higher pain scores and more functional deficits. Some patients with widespread pain may have underlying axSpA - this differential diagnosis needs to be taken into account when dealing with the diagnosis of FM in daily practice. Disclosure of Interest None declared
- Published
- 2015
9. SAT0374 Do Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis Respond Similarly Well to Nsaids? A Prospective Study Including Magnetic Resonance Imaging
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Dietmar Krause, L. Kalthoff, Uta Kiltz, H.-J. Menne, Heiner Appel, E. Saracbasi, E. Schmitz-Bortz, Frank Heldmann, X. Baraliakos, J. Braun, M. Igelmann, and F. Dybowski
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medicine.medical_specialty ,Ankylosing spondylitis ,medicine.diagnostic_test ,business.industry ,Radiography ,Immunology ,Mean age ,Magnetic resonance imaging ,medicine.disease ,Bone marrow edema ,Gastroenterology ,General Biochemistry, Genetics and Molecular Biology ,Surgery ,Rheumatology ,Internal medicine ,medicine ,Immunology and Allergy ,Axial spondyloarthritis ,Prospective cohort study ,business ,BASDAI - Abstract
Background Patients classified as axial spondyloarthritis (axSpA) may have ankylosing spondylitis (AS) or non-radiographic axSpA (nr-axSpA). Treatment recommendations for AS consider non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy. After an unsatisfactory response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) within 4 weeks (wk), anti-TNF agents are to be considered. However, it is unknown whether patients with nr-axSpA and AS respond similarly well to NSAIDs. Methods Consecutive patients (pts) with axSpA (n=50 with nr-axSpA and n=50 with AS) were included in a prospective study if their BASDAI level was ≥4, if they had not yet received the maximally approved dose of NSAIDs and if they had not been treated with anti-TNF agents to date. After inclusion the maximal dose of NSAIDs was administered over 1wk and the dose was then adapted in case of BASDAI Results nr-axSpA pts were more often female than AS pts (52% vs. 70%), were younger (mean age 37.6±11 vs. 41.9±12.3 years), and had a shorter symptom duration (7.3±9.1 vs. 14.6±11.837.6±11 years) but were similarly often HLA-B27+ (74% vs. 80%), all p=n.s. Significant differences between the groups were found in mean CRP levels (0.6±0.9 vs. 1.2±1.1) and mean MRI scores (3.1±3.0 vs. 6.7±5.4) in nr-axSpA vs. AS pts, respectively, both p 2.1 in 76% and 74% and a positive MRI occurred in 70% and 78% of pts with nr-axSpA and AS, respectively. After wk1 and wk4, both groups showed similarly increased rates in the NSAID-index and also similar responses to NSAIDs, with significant improvement from BL in all assessments with the exception of CRP levels and MRI-a scores, where almost no changes were observed. At wks 1 and 4, an ASAS20% response was found in 40% (21% with nr-axSpA and 19% with AS) and in 52% of pts (23% nr-axSpA and 29% AS), while ASAS partial remission was found in 10% (4% nr-axSpA and 6% AS) and in 16% of pts (7% nr-axSpA and 9% AS), respectively. However, 49% and 44% of all pts still had a BASDAI ≥4 at wks 1 and 4, and similar results were found for an ASDAS-CRP cut-off of ≥2.1, with 37% and 33% achieving this at wks 1 and 4 (no differences between nr-axSpA and AS). Conclusions Patients with nr-axSpA and AS show similar response rates to NSAID treatment. Although there was some improvement of ASAS response rates, 40-50% of pts with axSpA still showed BASDAI levels >4 after 4wk of intensive NSAID therapy and were, thus, eligible for anti-TNF therapy. Bone marrow edema on MRI and CRP levels were not influenced by continuous NSAID treatment. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.6085
- Published
- 2014
10. THU0108 Different Performance of the Major Disease Activity Measures ASDAS and BASDAI in Patients with Axial Spondyloarthritis Treated with Non-Steroidal Anti-Inflammatory Agents (NSAIDS) – Results from A Prospective Study
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E. Schmitz-Bortz, Dietmar Krause, Heiner Appel, E. Saracbasi, Frank Heldmann, H.-J. Menne, Uta Kiltz, X. Baraliakos, M. Igelmann, F. Dybowski, J. Braun, and L. Kalthoff
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musculoskeletal diseases ,medicine.medical_specialty ,business.industry ,Immunology ,General Biochemistry, Genetics and Molecular Biology ,Clinical trial ,Disease activity ,Rheumatology ,Non steroidal anti inflammatory ,Internal medicine ,Baseline characteristics ,Physical therapy ,Immunology and Allergy ,Medicine ,In patient ,Axial spondyloarthritis ,business ,Prospective cohort study ,BASDAI - Abstract
Background Measures for disease activity (BASDAI, ASDAS) are routinely used in patients (pts) with axial spondyloarthritis (axSpA). The ASDAS, a composite score that includes clinical measures and CRP, has high discriminatory capacity for assessment of disease activity. Clinical trial data showed that the ASDAS has a better sensitivity to change than the BASDAI in pts treated with TNF-blockers. However, there are no data on the comparison of ASDAS and BASDAI in axSpA pts treated with NSAIDs, which are recommended as first choice prior to a possible initiation of TNF-blockers. Objectives We compared the performance of BASDAI and ASDAS in assessing and predicting clinical response to intensive NSAID treatment in axSpA pts with high disease activity. Methods Consecutive pts with nr-axSpA and AS (n=50 each group) were included in a prospective study if their BASDAI level was ≥4, if they had not yet received the maximally approved dose of NSAIDs and if they had not been treated with anti-TNF agents to date. After inclusion the maximal dose of NSAIDs was administered over one week (wk) and the dose was then reduced in case of BASDAI Results Baseline characteristics of AS and nr-axSpA patients were similar. Prior to treatment, an ASDAS >2.1 was found in 74% and 76% of pts with AS and nr-axSpA, respectively. There was a significant decrease in both, ASDAS (BL: 2.5±0.6, 1wk: 1.9±0.8, 4wk: 1.6±0.8) and BASDAI (BL: 5.8±1.3 1wk: 4.1±2.1 4wk: 2.1±3.1). At wks 1 and 4, a BASDAI Conclusions BASDAI and ASDAS showed a similar magnitude of response on NSAID treatment in both AS and nr-axSpA. Of interest, the discriminative power of the ASDAS was much clearer in patients classified as nr-axSpA and especially in those who could be considered as candidates for anti-TNF treatment. These data challenge the concept of only using the BASDAI cut-off ≥4 for such treatment decisions. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.6086
- Published
- 2014
11. SAT0258 A Prospective Evaluation of the Diagnostic Value of Conventional Radiography, Ultrasound and MRI in Comparison to Clinical Examination for the Assessment of Heel and Knee Enthesitis in Patients With Spondyloarthritis and Controls
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X. Baraliakos, Dietmar Krause, E. Schmitz-Bortz, M. Igelmann, Frank Heldmann, C. Klink, L. Kalthoff, J. Braun, E. Saracbasi, Uta Kiltz, and F. Dybowski
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musculoskeletal diseases ,medicine.medical_specialty ,Achilles tendon ,Heel ,medicine.diagnostic_test ,business.industry ,Immunology ,Ultrasound ,Enthesitis ,Physical examination ,Enthesis ,General Biochemistry, Genetics and Molecular Biology ,Peripheral ,Surgery ,stomatognathic diseases ,medicine.anatomical_structure ,Rheumatology ,medicine ,Immunology and Allergy ,In patient ,Radiology ,medicine.symptom ,business - Abstract
Background Spondyloarthritides (SpA) are characterized by inflammatory and structural changes in the axial skeleton and in peripheral joints and entheses. Imaging has an essential role in the new classification criteria for axial SpA (axSpA) but not for peripheral manifestations. This is largely due to limited knowledge about the value of imaging to detect peripheral arthritis and enthesitis in SpA and whether it differentiates SpA from other conditions (non-SpA). Objectives To evaluate the significance of imaging procedures and their influence on treatment decision in patients with peripheral involvement of the lower limbs in SpA vs. non-SpA. Methods The main inclusion criterion was a painful heel or knee as reported by the patients, independent of the current treatment, and age Results The groups were similar in mean age (37.2±6.8 years), CRP (0.6±0.9mg/dl), NRS-pain (6.1±2.1) but symptom duration (SpA: 17.2±27.5 vs. non-SpA: 4.4±4.3 months) and HLA-B27 (67% in axSpA vs. 13% in non-SpA) differed (both n Pathologic findings were discovered most frequently using MRI of the heel (85.3% of patients), while x-rays were regarded pathologic in only 16.7% of patients (p Based on the clinical evaluation only, a change in treatment was suggested in 47% and 57% of patients with axSpA and non-SpA, respectively. Imaging (only US and MRI) contributed to a change of medication in an additional 13% of patients with axSpA but not in non-SpA patients. Conclusions In symptomatic patients with peripheral involvement of the knee or the heel, only erosions in the Achilles tendon area as assessed by US and thickness of the patellar tendon as assessed by MRI helped to differentiate SpA from non-SpA patients, while active enthesitis did not. Imaging of peripheral sites helped to make treatment decisions in patients with axSpA. Disclosure of Interest None Declared
- Published
- 2013
12. The Efficacy of Short-Term Bridging Strategies With High- and Low-Dose Prednisolone on Radiographic and Clinical Outcomes in Active Early Rheumatoid Arthritis: A Double-Blind, Randomized, Placebo-Controlled Trial.
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Krause D, Mai A, Klaassen-Mielke R, Timmesfeld N, Trampisch U, Rudolf H, Baraliakos X, Schmitz E, Fendler C, Klink C, Boeddeker S, Saracbasi-Zender E, Christoph HJ, Igelmann M, Menne HJ, Schmid A, Rau R, Wassenberg S, Sonuc N, Ose C, Schade-Brittinger C, Trampisch HJ, and Braun J
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- Adult, Delayed-Action Preparations, Double-Blind Method, Drug Therapy, Combination, Glucocorticoids therapeutic use, Humans, Methotrexate, Prednisolone therapeutic use, Treatment Outcome, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid diagnostic imaging, Arthritis, Rheumatoid drug therapy
- Abstract
Objective: In active early rheumatoid arthritis (RA), glucocorticoids are often used for bridging, due to the delayed action of methotrexate. This study was undertaken to compare the effect of 3 bridging strategies, including high-dose and low-dose prednisolone, on radiographic and clinical outcomes., Methods: Adult RA patients from 1 rheumatology hospital and 23 rheumatology practices who presented with moderate/high disease activity were randomized (1:1:1) to receive 60 mg prednisolone (high-dose prednisolone [HDP]) or 10 mg prednisolone (low-dose prednisolone [LDP]) daily (tapered to 0 mg within 12 weeks) or placebo. The 12-week intervention period was followed by 40 weeks of therapy at the physicians' discretion. The primary outcome measure was radiographic change at 1 year measured using the total modified Sharp/van der Heijde score (SHS). Disease activity was assessed with the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR)., Results: Of 395 randomized patients (HDP, n = 132; LDP, n = 131; placebo, n = 132), 375 (95%) remained in the modified intention-to-treat analysis. Mean ± SD changes in SHS scores in the 3 groups after 1 year were comparable: mean ± SD 1.0 ± 2.0 units in the HDP group, 1.1 ± 2.2 units in the LDP group, and 1.1 ± 1.5 units in the placebo group. The primary analysis showed no superiority of HDP compared to placebo (estimated difference of the mean change -0.04 [95% confidence interval (95% CI) -0.5, 0.4]). At week 12, the mean DAS28-ESR differed: -0.6 (95% CI -1.0, -0.2) for HDP versus placebo; -0.8 (95% CI -1.2, -0.5) for LDP versus placebo. At week 52, there was no significant difference in DAS28-ESR between the 3 groups (range 2.6-2.8). Serious adverse events occurred similarly often., Conclusion: Short-term glucocorticoid bridging therapy at a high dose showed no benefit with regard to progression of radiographic damage at 1 year., (© 2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
- Published
- 2022
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13. The Structured Delegation of Medical Care Services for Patients With Inflammatory Rheumatic Diseases.
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Krause D, Mai A, Denz R, Johow J, Reese JP, Westerhoff B, Klaaßen-Mielke R, Timmesfeld N, Rittstieg A, Saracbasi-Zender E, Günzel J, Klink C, Schmitz E, Fendler C, Raub W, Böddeker S, Dybowski F, Hübner G, Menne HJ, Lakomek HJ, Sarholz M, Trampisch U, Trampisch HJ, and Braun J
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- Germany epidemiology, Humans, Rheumatologists, Arthritis, Rheumatoid therapy, Quality of Life
- Abstract
Background: In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care., Methods: Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians' tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. "Non-inferiority," in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients' health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526)., Results: From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine-Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p <0.001 for non-inferiority). Superiority with respect to health-related quality of life was not demonstrated (adjusted difference = 0.02 [-0.02; 0.05], p = 0.285)., Conclusion: Team-based care, with greater integration of SRAs, is just as good as standard care in important respects. Trained SRAs can effectively support rheumatologists in the care of stable patients with RA or PsA.
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- 2022
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14. Patients with fibromyalgia rarely fulfil classification criteria for axial spondyloarthritis.
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Baraliakos X, Regel A, Kiltz U, Menne HJ, Dybowski F, Igelmann M, Kalthoff L, Krause D, Saracbasi-Zender E, Schmitz-Bortz E, and Braun J
- Subjects
- Adult, Chronic Pain classification, Chronic Pain diagnosis, Female, Fibromyalgia classification, Fibromyalgia diagnosis, Follow-Up Studies, Humans, Male, Middle Aged, Pain Measurement, Prospective Studies, Radiography methods, Severity of Illness Index, Spondylarthritis complications, Spondylarthritis diagnosis, Surveys and Questionnaires, Chronic Pain etiology, Clinical Competence, Fibromyalgia etiology, Rheumatologists standards, Spondylarthritis classification
- Abstract
Background: The Assessments of Spondyloarthritis international Society (ASAS) classification criteria for axial spondyloarthritis (axSpA) have been criticized because of insufficient differentiation towards FM. The aim of this study was to compare the performance of currently used classification criteria in patients diagnosed with axSpA or FM., Methods: Patients were prospectively included if diagnosed with axSpA or FM by the treating rheumatologist and evaluated by an independent examiner for fulfilment of the classification criteria for axSpA (ASAS criteria) and/or FM (1990 ACR classification and 2010 ACR diagnostic criteria). Patients with axSpA were stratified based on classification as non-radiographic axSpA (nr-axSpA) or AS. Symptom severity was assessed by established disease-related questionnaires., Results: Overall, 300 patients were included, 100 with FM and 200 with axSpA of which 100 each had nr-axSpA and AS. Almost all FM patients fulfilled the 2010 (100%) and 1990 ACR criteria (98%) for FM, but only 2% fulfilled the ASAS criteria. When calculations were based on only the FM patients with available HLA-B27 results (n = 40), the proportion fulfilling the ASAS criteria was 5%. All axSpA patients met the ASAS criteria but also the 2010 (24%) and 1990 (13.5%) FM criteria. More patients with AS (29% and 19%) than with nr-axSpA (19% and 8%) fulfilled the 2010 and 1990 FM criteria, respectively., Conclusion: FM patients only rarely fulfil classification criteria for axSpA but some axSpA patients also fulfil FM criteria. Since this was more frequent in patients with AS it may be related to the severity and duration of chronic pain in axSpA patients. Assessment instruments evaluated in axSpA are not disease-specific. The phenomenon of central pain sensitization in rheumatic diseases deserves more study.
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- 2018
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15. Chronic but not inflammatory changes at the Achilles' tendon differentiate patients with peripheral spondyloarthritis from other diagnoses - Results from a prospective clinical trial.
- Author
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Baraliakos X, Kiltz U, Appel H, Dybowski F, Igelmann M, Kalthoff L, Klink C, Krause D, Saracbasi E, Schmitz-Bortz E, Rahmeh F, and Braun J
- Abstract
Background: Imaging has an essential role in the new spondyloarthritis (SpA) classification criteria for axial but not for peripheral manifestations. We evaluated the impact of imaging findings for identification and treatment decisions in patients with peripheral spondyloarthritis (pSpA) and controls (non-SpA)., Methods: Patients with pSpA (Assessment of SpA international Society criteria, n=30) and non-SpA (n=30), aged <45 years, with painful heels or knees, were recruited. Conventional radiography, grey-scale ultrasound including power Doppler (US/PDUS) and MRI of symptomatic areas were performed to assess inflammatory and structural changes. Mann-Whitney U test was used for group comparisons., Results: In total, 105 painful entheses (71 heels, 34 knees) in 60 patients were examined. Differences between diagnoses were found for symptom duration (pSpA: 17.2±27.5 vs non-SpA: 4.4±4.3 months), human leucocyte antigen B27 prevalence (67% vs 13%) and gender distribution (53.3% vs 20% male, respectively), all P<0.05. Logistic regression analysis for baseline differences showed that chronic changes (erosions and calcification) in the heel were more frequent in pSpA versus non-SpA by US/PDUS (62.5% vs 28.6% patients and 59.5% vs 26.5% entheses, P<0.05). Inflammatory changes in heel or knee by US/PDUS and MRI could not differentiate between non-SpA and pSpA., Conclusions: Differentiation between pSpA and non-SpA was only possible based on structural but not inflammatory changes in the heels and knees of symptomatic patients. US/PDUS was superior to MRI for this purpose. These findings imply that pSpA is associated with erosive changes at enthesitic sites, while inflammation and susceptibility are of minor influence for the development of erosions and calcification to pSpA., Competing Interests: Competing interests: None declared.
- Published
- 2017
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16. Efficiency of treatment with non-steroidal anti-inflammatory drugs according to current recommendations in patients with radiographic and non-radiographic axial spondyloarthritis.
- Author
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Baraliakos X, Kiltz U, Peters S, Appel H, Dybowski F, Igelmann M, Kalthoff L, Krause D, Menne HJ, Saracbasi-Zender E, Schmitz-Bortz E, Vigneswaran M, and Braun J
- Subjects
- Adult, C-Reactive Protein immunology, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Practice Guidelines as Topic, Prospective Studies, Radiography, Sacroiliac Joint diagnostic imaging, Spondylarthritis diagnostic imaging, Spondylarthritis drug therapy, Spondylarthritis immunology, Spondylitis, Ankylosing diagnostic imaging, Spondylitis, Ankylosing immunology, Treatment Outcome, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Cyclooxygenase 2 Inhibitors therapeutic use, Spondylitis, Ankylosing drug therapy
- Abstract
Objective: NSAIDs are first-line therapy in axial SpA (axSpA). The proportion of patients responding to NSAIDs and differences between AS and non-radiographic axSpA (nr-axSpA) in this regard have not been studied in detail to date. The aim of this study was to examine the proportion of patients with AS and nr-axSpA responding to NSAIDs according to current treatment recommendations., Methods: Consecutive anti-TNF-naïve patients with nr-axSpA and AS (n = 50 each) were included if their BASDAI score was ⩾4 without having received maximal NSAID doses. In case of a BASDAI score ⩾4 1 week later, another NSAID was prescribed. For the next 3 weeks, continuous intake of maximal doses was recommended but patients could reduce doses in case of intolerance or improvement. MRI of the SI joints was performed at baseline and week 4., Results: All outcomes except for CRP and MRI scores improved significantly after 4 weeks of NSAIDs, with no difference between axSpA subgroups. An Assessment of SpondyloArthritis international Society 40% (ASAS40) response and partial remission rates were 35 and 16% at week 4, respectively. At the same time point, a BASDAI score ⩾4 was still present in 44% of patients, 30% of which had reduced NSAID doses, partly due to intolerance (38%). Only 13% of all patients had continuously taken NSAIDs at the maximal dosage, but there was no difference in the efficacy outcome compared with those who had taken reduced doses., Conclusion: AS and nr-axSpA patients had similar response rates to NSAIDs while objective signs of inflammation did not change over 4 weeks. Only a minority of patients was willing to take maximal doses of NSAIDs, and ⩾40% patients remained candidates for TNF blockers. These results may influence future trial designs., (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
- Published
- 2017
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17. Optimizing the identification of patients with axial spondyloarthritis in primary care--the case for a two-step strategy combining the most relevant clinical items with HLA B27.
- Author
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Braun A, Gnann H, Saracbasi E, Grifka J, Kiltz U, Letschert K, and Braun J
- Subjects
- Adult, Aged, Axis, Cervical Vertebra pathology, Biomarkers analysis, Cohort Studies, Female, HLA-B27 Antigen analysis, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Sacroiliac Joint physiopathology, Sensitivity and Specificity, Severity of Illness Index, HLA-B27 Antigen immunology, Primary Health Care methods, Spondylarthritis diagnosis, Spondylarthritis immunology
- Abstract
Objectives: The combination of clinical items suggestive of inflammatory back pain has proved useful for early identification of patients with axial SpA (axSpA) in primary care. However, whether HLA B27 contributes to that is unclear, and published recommendations have advised against it. In this study, we reanalysed data of that trial in relation to the HLA B27 results., Methods: Consecutive patients <45 years old (n = 950) with back pain (BP) >2 months presenting to 143 orthopaedists were referred to 36 rheumatologists who made the diagnosis. The predictive value of HLA B27 (n = 298) alone and in combination, including modelling and a two-step strategy, was calculated., Results: Among all patients (mean age 36 years, 52% female, median duration of BP 32 months), 107 had axSpA (36%). Using a simple model, HLA B27 alone performed better than all combinations of clinical items and adding it did not improve likelihood ratios (LRs). Using modelling, two-phase strategies were analysed. Additional items were only relevant in the HLA B27-negative group: improvement by movement, buttock pain and psoriasis. Combining this information revealed the presumably best strategy to predict axSpA in primary care: more than one of these items or HLA B27 need to be present (sensitivity 80.4%, specificity 75.4%, LR+ 3.27 and LR- 0.26)., Conclusion: This is the first study to show that patients with axSpA are more reliably identified in primary care by a strategy that includes HLA B27. Because of the two-step approach, the test needs to be performed in only about half of patients with chronic BP.
- Published
- 2013
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18. [Practical problems by implementation of vaccination recommendations].
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Fendler C, Saracbasi E, Dybowski F, Heldmann F, and Braun J
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- Antibody Formation drug effects, Antibody Formation immunology, Antirheumatic Agents adverse effects, Antirheumatic Agents therapeutic use, Biological Products adverse effects, Biological Products therapeutic use, Cooperative Behavior, Female, Germany, Glucocorticoids adverse effects, Glucocorticoids therapeutic use, Humans, Immunization Schedule, Immunosuppressive Agents adverse effects, Immunosuppressive Agents therapeutic use, Interdisciplinary Communication, Male, Medical Records, Methotrexate adverse effects, Methotrexate therapeutic use, Middle Aged, Patient Admission, Patient Compliance, Rheumatic Diseases drug therapy, Immunization Programs, Rheumatic Diseases immunology
- Abstract
Patients with inflammatory rheumatic diseases are known to have an increased risk of infections due to the rheumatic disease itself and due to therapy with immunosuppressive agents. The most important procedure to prevent infections is vaccinations, which are usually well-tolerated. The German National Commission for Immunization ( STIKO) has published recommendations for patients with an immunodeficiency. The German Society of Rheumatology (DGRh) has generally implemented these recommendations for patients with chronic inflammatory rheumatic diseases. The immunization status of patients with rheumatic diseases is of increasing importance in routine patient care because some of the recently approved drugs may influence the strength of the immune response to vaccination. However, there is almost no information about the current immunization status and the willingness of patients with rheumatic diseases to undergo vaccination procedures in Germany. There are also no epidemiologic data on the implementation of recommendations for immunization at the level of general practitioners. Here we present the results of a prospective study on the efficacy of standardized recommendations for immunization given to different patient groups with rheumatic diseases treated in a hospital specialized in rheumatology.
- Published
- 2012
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19. [Generalized osteoarthritis in a young adult with type II collagenopathy].
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Dybowski F, Moos F, Saracbasi-Zender E, Heldmann F, and Braun J
- Subjects
- Age Factors, Diagnosis, Differential, Humans, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae pathology, Male, Osteoarthritis diagnosis, Osteoarthritis, Hip diagnosis, Osteoarthritis, Knee diagnosis, Osteoarthritis, Spine diagnostic imaging, Osteochondrodysplasias diagnosis, Osteochondrodysplasias genetics, Osteoporotic Fractures diagnostic imaging, Radiography, Thoracic Vertebrae diagnostic imaging, Thoracic Vertebrae pathology, Young Adult, Collagen Type II genetics, Osteoarthritis genetics, Osteochondrodysplasias complications
- Abstract
History and Admission Findings: In the 20-year-old patient increasing arthralgia since the age of seven years had caused functional impairment. As seronegative osteodestructive rheumatoid arthritis had been suspected, he was treated with methotrexate and steorid for ovemore than one year, without success.r, Investigations: The clinical examination revealed a compromised function of the knee and hip joints. Conventional radiographs showed severe degenerative changes in these regions. The radiographs of the lumbar and the thoracic spine were suggestive of osteoporotic fractures., Diagnosis, Treatment and Course: The clinical and radiological findings led to the suspicion of a hereditary collagenous disease. Genetic analyses revealed a COL2A1 mutation. The treatment included analgesics, non-steroidal antirheumatic drugs, opiates and regular physiotherapy to build up and maintain muscle strength., Conclusion: In young adult patients with osteoarthritis mutations in the COL2A1 gene should considered. This mutation with the substitution pArg75Cys should be in focus because of the phenotypes in clinical manifestations., (© Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2011
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20. Identifying patients with axial spondyloarthritis in primary care: how useful are items indicative of inflammatory back pain?
- Author
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Braun A, Saracbasi E, Grifka J, Schnitker J, and Braun J
- Subjects
- Adolescent, Adult, Age Distribution, Age of Onset, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Chronic Disease, Diagnosis, Differential, Early Diagnosis, Epidemiologic Methods, Female, HLA-B27 Antigen analysis, Humans, Male, Patient Selection, Primary Health Care methods, Referral and Consultation, Spondylarthritis complications, Spondylarthritis drug therapy, Spondylitis, Ankylosing complications, Spondylitis, Ankylosing diagnosis, Spondylitis, Ankylosing drug therapy, Young Adult, Axis, Cervical Vertebra, Back Pain etiology, Spondylarthritis diagnosis
- Abstract
Background: The value of clinical items defining inflammatory back pain to identify patients with axial spondyloarthritis (SpA) in primary care is unclear., Objective: To identify predictive clinical parameters for a diagnosis of axial SpA in patients with chronic back pain presenting in primary care., Methods: Consecutive patients aged < 45 years (n=950) with back pain for > 2 months who presented to orthopaedic surgeons (n=143) were randomised based on four key questions for referral to rheumatologists (n=36) for diagnosis., Results: The rheumatologists saw 322 representative patients (mean age 36 years, 50% female, median duration of back pain 30 months). 113 patients (35%) were diagnosed as axial SpA (62% HLA B27+), 47 (15%) as ankylosing spondylitis (AS) and 66 (21%) as axial non-radiographic SpA (nrSpA). Age at onset ≤ 35 years, improvement by exercise, improvement with non-steroidal anti-inflammatory drugs, waking up in the second half of the night and alternating buttock pain were identified as most relevant for diagnosing axial SpA by multiple regression analysis. Differences between AS and nrSpA were detected. No single item was predictive, but ≥ 3 items proved useful for good sensitivity and specificity by receiver operating characteristic modelling., Conclusion: This study shows that a preselection in primary care of patients with back pain based on a combination of clinical items is useful to facilitate the diagnosis of axial SpA.
- Published
- 2011
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21. Update on biologic therapy in the management of axial spondyloarthritis.
- Author
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Heldmann F, Dybowski F, Saracbasi-Zender E, Fendler C, and Braun J
- Subjects
- Adalimumab, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Antirheumatic Agents therapeutic use, Etanercept, Humans, Immunoglobulin G therapeutic use, Infliximab, Receptors, Tumor Necrosis Factor therapeutic use, Tumor Necrosis Factor-alpha antagonists & inhibitors, Biological Therapy, Spondylarthritis therapy
- Abstract
Axial spondyloarthritis, which includes ankylosing spondylitis and psoriatic spondyloarthritis, is an important subtype of the spondyloarthritides. Tumor necrosis factor (TNF) antagonists are effective therapies for this partially heterogeneous group of rheumatic diseases in terms of signs, symptoms, and functioning, but they do not seem to substantially inhibit radiographic progression, which is mainly new bone formation in ankylosing spondylitis. However, they clearly reduce inflammation, as shown by MRI. TNF blockers are also efficacious in the treatment of extraspinal features of spondyloarthritis. In addition, evidence indicates that anti-TNF therapy works well in early axial disease. Other biologics are currently being investigated, as alternatives are needed for patients who fail anti-TNF therapy.
- Published
- 2010
- Full Text
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