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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

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.

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

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

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

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