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Herne, Germany

Braun J.,Rheumazentrum Ruhrgebiet | Inman R.,University of Toronto
Annals of the Rheumatic Diseases

Inflammatory back pain (IBP) is the leading symptom of patients with spondyloarthritis (SpA), but its value for diagnosis, classification and screening in primary care is not well defined. Although often used since 1977, its clinical significance has not been extensively studied. As shown recently, most but clearly not all patients with axial SpA have IBP. Therefore IBP has not been included in current criteria for axial SpA as a first-line criterion. The value of IBP for diagnosis of SpA increases in the presence of other more or less sensitive and specific features of SpA such as response to exercise and physical therapy and/or treatment with non-steroidal antiinflammatory agents. Source

MacHado P.,University of Coimbra | MacHado P.,Leiden University | Landewe R.,Maastricht University | Lie E.,Diakonhjemmet Hospital | And 4 more authors.
Annals of the Rheumatic Diseases

Background: The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in ankylosing spondylitis (AS). It fulfi ls important aspects of truth, feasibility and discrimination. Criteria for disease activity states and improvement scores are important for use in clinical practice, observational studies and clinical trials and so far have not been developed for the ASDAS. Objective: To determine clinically relevant cut-off values for disease activity states and improvement scores using the ASDAS. Methods: For the selection of cut-offs data from the Norwegian disease modifying antirheumatic drug (NORDMARD) registry, a cohort of patients with AS starting conventional or biological DMARDs, were used. Receiver operating characteristic analysis against several external criteria was performed and several approaches to determine the optimal cut-offs used. The fi nal choice was made on clinical and statistical grounds, after debate and voting by Assessment of SpondyloArthritis international Society members. Crossvalidation was performed in NOR-DMARD and in Ankylosing Spondylitis Study for the Evaluation of Recombinant Infl iximab Therapy, a database of patients with AS participating in a randomised placebo-controlled trial with a tumour necrosis factor blocker. Results: Four disease activity states were chosen by consensus: inactive disease, moderate, high and very high disease activity. The three cut-offs selected to separate these states were: 1.3, 2.1 and 3.5 units. Selected cut-offs for improvement were: change ≥1.1 units for clinically important improvement and change ≥2.0 units for major improvement. Results: of the crossvalidation strongly supported the cut-offs. Conclusions: Cut-off values for disease activity states and improvement using the ASDAS have been developed. They proved to have external validity and a good performance compared to existing criteria. Source

Braun J.,Rheumazentrum Ruhrgebiet | Deodhar A.,Oregon Health And Science University | Inman R.D.,University of Toronto | Van Der Heijde D.,Leiden University | And 3 more authors.
Annals of the Rheumatic Diseases

Objective: To assess the efficacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis. Methods: At baseline, patients with active ankylosing spondylitis (n=356) were randomly assigned (1:1.8:1.8) to subcutaneous injections of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3) every 4 weeks. At week 16, patients in groups 1 and 2 with <20% improvement in total back pain and morning stiffness entered early escape to 50 or 100 mg, respectively. At week 24, patients still receiving placebo crossed over to golimumab 50 mg. Findings through week 24 were previously reported; those through week 104 are presented herein. Results: At week 104, 38.5%, 60.1% and 71.4% of patients in groups 1, 2 and 3, respectively, had at least 20% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20); 38.5%, 55.8% and 54.3% had an ASAS40 response and 21.8%, 31.9% and 30.7% were in ASAS partial remission. Mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were <3 at week 104 for all the treatment regimens. Golimumab safety through week 104 was similar to that through week 24. Conclusion: Clinical response that was achieved by patients receiving golimumab through 24 weeks was sustained through 52 and 104 weeks. The golimumab safety profile appeared to be consistent with the known safety profile of tumour necrosis factor inhibitors. Source

Braun J.,Rheumazentrum Ruhrgebiet
Clinical and Experimental Rheumatology

The spondyloarthritides (SpA) are a heterogenous group of rheumatic diseases which are genetically linked. The strongest genetic factors, HLA B27, ERAP-1 and IL-23R, are found at variable rates in subgroups. The new nomenclature differentiates predominantly axial SpA (axSpA) from predominantly peripheral SpA (pSpA). Axial SpA (Ax-SpA) is further classified as classical ankylosing spondylitis (AS) and a nonradiographic form, nr-axSpA, which may occur in association with psoriasis (Pso) or chronic inflammatory bowel disease (IBD). Peripheral SpA includes patients with psoriatic arthritis (PsA) and IBD, patients who report a triggering infection (reactive arthritis), and other patients who may be classified simply as 'undifferentiated'. The most relevant target of therapy clinically is reduction of disease activity, which is associated with control toward ablation of inflammation, normalisation and/or improvement of function and mobility, prevention of osteoporotic fractures, and inhibition of structural changes (new bone formation) in the spine. © Copyright Clinical and Experimental Rheumatology 2012. Source

Poddubnyy D.,Charite - Medical University of Berlin | Rudwaleit M.,Endokrinologikum | Haibel H.,Charite - Medical University of Berlin | Listing J.,German Rheumatism Research Center | And 4 more authors.
Annals of the Rheumatic Diseases

Objective: To investigate the influence of non-steroidal anti-inflammatory drugs (NSAIDs) intake on radiographic spinal progression over 2 years in patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA). Methods: 164 patients with axial SpA (88 with AS and 76 with non-radiographic axial SpA) were selected for this analysis based on availability of spinal radiographs at baseline and after 2 years of follow-up and the data on NSAIDs intake. Spinal radiographs were scored by two trained readers in a concealed randomly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) system. An index of the NSAID intake counting both dose and duration of drug intake was calculated. Results: High NSAIDs intake (NSAID index≥50) in AS was associated with lower likelihood of significant radiographic progression defined as an mSASSS worsening by ≥2 units: OR=0.15, 95% CI 0.02 to 0.96, p=0.045 (adjusted for baseline structural damage, elevated C reactive protein (CRP) and smoking status) in comparison with patients with low NSAIDs intake (NSAID index<50). This effect was most pronounced in patients with baseline syndesmophytes plus elevated CRP: mean mSASSS progression was 4.36±4.53 in patients with low NSAIDs intake versus 0.14±1.80 with high intake, p=0.02. In non-radiographic axial SpA, no significant differences regarding radiographic progression between patients with high and low NSAIDs intake were found. Conclusion: A high NSAIDs intake over 2 years is associated with retarded radiographic spinal progression in AS. In non-radiographic axial SpA this effect is less evident, probably due to a low grade of new bone formation in the spine at this stage.. Source

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