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Berlin, Germany

Poddubnyy D.,Charite - Medical University of Berlin | Conrad K.,Charite - Medical University of Berlin | Haibel H.,Charite - Medical University of Berlin | Syrbe U.,Charite - Medical University of Berlin | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: To investigate the role of serum vascular endothelial growth factor (VEGF) as a predictor of radiographic spinal progression in patients with axial spondyloarthritis (axSpA). Methods: Altogether, 172 patients with definite axSpA (95 with ankylosing spondylitis and 77 with non-radiographic axSpA) were included in this study. Spinal radiographs obtained at baseline and after 2 years of follow-up were scored independently by two trained readers in a concealed and randomly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring system and for the presence of syndesmophytes. Radiographic spinal progression after 2 years was defined as (1) mSASSS worsening by ≥2 units, and (2) new syndesmophyte formation or formation of a bridging syndesmophyte from two single syndesmophytes. Serum VEGF levels were detected at baseline. Results: Mean baseline VEGF values were significantly higher in patients with mSASSS worsening by ≥2 units after 2 years (n=22) than in those without progression (562±357 vs 402±309 pg/mL, respectively, p=0.027) and in patients with syndesmophyte formation (n=18) again as compared with those without new bone formation (579±386 vs 404±307 pg/mL, respectively, p=0.041). VEGF as a predictor of radiographic spinal progression performed especially well in patients who were already at high risk for such a progression due to the presence of syndesmophytes at baseline (n=48). In these patients, a VEGF serum level of >600 pg/mL had a sensitivity of 53%, a specificity of 97% and an OR=36.6 (95% CI 3.9 to 341.5) as a predictor of mSASSS worsening by ≥2 units. For syndesmophyte formation, elevated VEGF demonstrated a sensitivity of 47%, a specificity of 94% and an OR=13.6 (95% CI 2.4 to 78.3). Conclusions: An elevated serum level of VEGF (>600 pg/mL) is highly specific as a predictor of radiographic spinal progression in patients with axSpA, especially in patients who are at high risk for further progression due to the presence of syndesmophytes. © 2013 BMJ Publishing Group Ltd & European League Against Rheumatism. Source

Rudwaleit M.,Endokrinologikum Berlin | Marker-Hermann E.,HSK Dr. Horst Schmidt Kliniken GmbH
Zeitschrift fur Rheumatologie | Year: 2012

Low back pain is a frequent health problem and causes substantial costs. Between 2007 and 2010 a panel of interdisciplinary experts in Germany developed evidence-based national guidelines for the management of nonspecific low back pain. These guidelines cover diagnosis (red flags and yellow flags), treatment recommendations and health care algorithms. In acute nonspecific low back pain diagnostic imaging is not indicated and should be avoided. Education and patient information, maintenance of routine daily physical activities and pain therapy as needed are the cornerstones of acute nonspecific low back pain therapy. In order to prevent the development of chronic back pain in patients with acute nonspecific back pain, the early identification of parameters predictive of a high risk of chronicity (yellow flags) is of particular importance even in primary care. © Springer-Verlag 2012. Source

Poddubnyy D.,Charite - Medical University of Berlin | Rudwaleit M.,Endokrinologikum Berlin
Expert Opinion on Biological Therapy | Year: 2013

Introduction: Following its marketing authorization for the treatment of ankylosing spondylitis (AS) in 2006 in the United States und in the European Union, adalimumab became one of the most frequently prescribed tumor necrosis factor (TNF) α blockers available for this indication. Recently, the label for adalimumab was extended to nonradiographic axial spondyloarthritis (nr-axSpA), which might be considered as an early stage of AS. The increasing number of patients with AS being treated with adalimumab raises issues concerning long-term safety, efficacy in the prevention of structural damage in the spine and high treatment costs. Areas covered: Herein, we summarize data on efficacy and safety of adalimumab treatment in AS and nr-axSpA obtained over the past 5 years. Expert opinion: Adalimumab is clinically effective and reasonably safe in the short-term and long-term treatment of patients with AS who do not respond to standard therapy. Recent data indicate good efficacy of adalimumab also in patients with nr-axSpA but only in the presence of objective signs of active inflammation. Yet unresolved questions relate to the ability of adalimumab to stop or retard structural damage development in the spine in patients with AS and nr-axSpA. The introduction of biosimilar drugs in the near future may potentially reduce the currently very high treatment costs associated with adalimumab treatment. © 2013 Informa UK, Ltd. Source

Landewe R.,Atrium Medical | Braun J.,Rheumazentrum Ruhrgebiet | Deodhar A.,Oregon Health And Science University | Dougados M.,Cochin Hospital | And 11 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPIDaxSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA). Methods Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear. Results Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (-2.28 vs -0.40), BASDAI (-3.05 vs -1.05), and BASMI (-0.52 vs -0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported. Conclusions CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients. Source

Poddubnyy D.,Charite - Medical University of Berlin | Brandt H.,Charite - Medical University of Berlin | Vahldiek J.,Charite - Medical University of Berlin | Spiller I.,Charite - Medical University of Berlin | And 3 more authors.
Annals of the Rheumatic Diseases | Year: 2012

Objective: This study was aimed at investigating the frequencies of non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) diagnoses and their ratios in relation to symptom duration in patients referred because of chronic back pain and suspicion of axial SpA. Methods: In this monocentre study, orthopaedists and primary care physicians were requested to refer patients with chronic low back pain (duration >3 months) and onset of back pain before 45 years of age to a SpA-specialised rheumatology outpatient clinic for further diagnostic investigation, if proposed screening parameters were present. The ratio of nr-axSpA to AS was analysed in relation to the duration of symptoms. Results: A diagnosis of definite axial SpA was made in 43.7% of the referred patients (n=522). Axial SpA was diagnosed in a similar percentage of about 50% if back pain duration was <9 years but decreased to 36% if symptom duration was >9 years. Nr-axSpA represented the majority of patients (67.3%) only if duration of back pain was 1 year and less at the time of referral. Between 1 and 6 years of back pain duration the probability of nr-axSpA and AS was nearly equal (1-3 years: 52.5% and 47.5%, respectively; 3-6 years: 53.7% and 46.3%, respectively). In patients with back pain duration of 6-9 years, AS was more likely (61.1%) to be diagnosed than nr-axSpA (38.9%), and this increased further over time. Conclusions: Non-radiographic axial SpA represents an important differential diagnosis of back pain, especially in patients with recent symptom onset. Source

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