Rheumazentrum Ruhrgebiet

Herne, Germany

Rheumazentrum Ruhrgebiet

Herne, Germany
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Braun J.,Rheumazentrum Ruhrgebiet
Rheumatology (United Kingdom) | Year: 2016

PsA is an immune-mediated chronic inflammatory disease that affects both skin and joints; it is a heterogeneous disease characterized by synovitis, enthesitis, dactylitis and spondylitis. The impact on patients and the burden of disease are substantial. For assessment of the disease, patient-reported outcomes are increasingly important. Conventional therapy consists of NSAIDs, local and systemic CSs, and synthetic and biological DMARDs. While MTX, LEF, SSZ and CYC are the synthetic drugs mainly used, TNF-α blocking agents have represented the majority of biologics used in the last decade (infliximab, etanercept, adalimumab, certolizumab and golimumab). Treat-to-target strategies have been used successfully in PsA. This review concentrates on new developments, mainly covering biologic agents with an IL-17 inhibitor (secukinumab) and an anti-IL-23 agent (ustekinumab), but also synthetic drugs, including a novel phosphodiesterase-4 inhibitor (apremilast) and a Janus kinase inhibitor (tofacitinib) that blocks mainly Jak3 and Jak1 and, to a lesser extent, Jak2. The efficacy of some of these new agents may be even better for the skin than for the joints. © The Author 2016.

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 | Year: 2012

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.

Poddubnyy D.,Charité - Medical University of Berlin | Rudwaleit M.,Endokrinologikum | Haibel H.,Charité - Medical University of Berlin | Listing J.,German Rheumatism Research Center | And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2012

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..

Baeten D.,University of Amsterdam | Sieper J.,Charité - Medical University of Berlin | Braun J.,Rheumazentrum Ruhrgebiet | Baraliakos X.,Rheumazentrum Ruhrgebiet | And 8 more authors.
New England Journal of Medicine | Year: 2015

Background: Secukinumab is an anti-interleukin-17A monoclonal antibody that has been shown to control the symptoms of ankylosing spondylitis in a phase 2 trial. We conducted two phase 3 trials of secukinumab in patients with active ankylosing spondylitis. Methods: In two double-blind trials, we randomly assigned patients to receive secukinumab or placebo. In MEASURE 1, a total of 371 patients received intravenous secukinumab (10 mg per kilogram of body weight) or matched placebo at weeks 0, 2, and 4, followed by subcutaneous secukinumab (150 mg or 75 mg) or matched placebo every 4 weeks starting at week 8. In MEASURE 2, a total of 219 patients received subcutaneous secukinumab (150 mg or 75 mg) or matched placebo at baseline; at weeks 1, 2, and 3; and every 4 weeks starting at week 4. At week 16, patients in the placebo group were randomly reassigned to subcutaneous secukinumab at a dose of 150 mg or 75 mg. The primary end point was the proportion of patients with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16. Results: In MEASURE 1, the ASAS20 response rates at week 16 were 61%, 60%, and 29% for subcutaneous secukinumab at doses of 150 mg and 75 mg and for placebo, respectively (P<0.001 for both comparisons with placebo); in MEASURE 2, the rates were 61%, 41%, and 28% for subcutaneous secukinumab at doses of 150 mg and 75 mg and for placebo, respectively (P<0.001 for the 150-mg dose and P = 0.10 for the 75-mg dose). The significant improvements were sustained through 52 weeks. Infections, including candidiasis, were more common with secukinumab than with placebo during the placebo-controlled period of MEASURE 1. During the entire treatment period, pooled exposure-adjusted incidence rates of grade 3 or 4 neutropenia, candida infections, and Crohn's disease were 0.7, 0.9, and 0.7 cases per 100 patientyears, respectively, in secukinumab-treated patients. Conclusions: Secukinumab at a subcutaneous dose of 150 mg, with either subcutaneous or intravenous loading, provided significant reductions in the signs and symptoms of ankylosing spondylitis at week 16. Secukinumab at a subcutaneous dose of 75 mg resulted in significant improvement only with a higher intravenous loading dose. Copyright © 2015 Massachusetts Medical Society. All rights reserved.

Poddubnyy D.,Charité - Medical University of Berlin | Haibel H.,Charité - Medical University of Berlin | Listing J.,German Rheumatism Research Center | Marker-Hermann E.,Horst Schmidt Kliniken | And 4 more authors.
Arthritis and Rheumatism | Year: 2012

Objective To assess prospectively the rates and to explore predictors of spinal radiographic progression over 2 years in a cohort of patients with early axial spondylarthritis (SpA). Methods Two hundred ten patients with axial SpA from the German Spondyloarthritis Inception Cohort were selected for this analysis based on the availability of radiographs at baseline and after 2 years of followup. Spinal radiographs were scored by 2 trained readers in a blinded, randomly selected order according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Spinal radiographic progression was defined as worsening of the mean mSASSS by ≥2 units over 2 years. Results Among the patients with axial SpA, 14.3% showed spinal radiographic progression after 2 years (20% of those with AS and 7.4% of those with nonradiographic axial SpA). The following parameters were independently associated with spinal radiographic progression: presence of syndesmophytes at baseline (odds ratio [OR] 6.29, P < 0.001), elevated levels of markers of systemic inflammation (for the erythrocyte sedimentation rate, OR 4.04, P = 0.001; for C-reactive protein level time-averaged over 2 years, OR 3.81, P = 0.001), and cigarette smoking (OR 2.75, P = 0.012). These associations were confirmed by multivariate logistic regression analysis. No clear association with spinal radiographic progression was observed for HLA-B27 status, sex, age, disease duration, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, presence of peripheral arthritis, enthesitis, psoriasis, treatment with nonsteroidal antiinflammatory drugs, or treatment with disease-modifying antirheumatic drugs at baseline. Conclusion The presence of radiographic damage at baseline (syndesmophytes), elevated levels of acute-phase reactants, and cigarette smoking were all independently associated with spinal radiographic progression in patients with early axial SpA. Copyright © 2012 by the American College of Rheumatology.

Braun J.,Rheumazentrum Ruhrgebiet
Clinical and Experimental Rheumatology | Year: 2010

Methotrexate (MTX) has been used for the treatment of rheumatic diseases, especially rheumatoid arthritis (RA), for some decades now. Although it had been known from pharmacokinetic studies for quite some time already that the bioavailability of MTX is superior when administered parenterally rather than orally, this had never been formally proven to be clinically relevant. In a recent randomised clinical trial, the two ways of administration have been directly compared. The fact that the patient group that received MTX s.c. had better clinical outcome than the oral group can be considered as proof that this hypothesis has now been confirmed. Although this result does not mean that every patient will be in need of parenteral administration of MTX, it suggests that very active patients and those with a worse prognosis may have more benefit from this strategy. © Copyright CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2010.

Braun J.,Rheumazentrum Ruhrgebiet | Inman R.,University of Toronto
Annals of the Rheumatic Diseases | Year: 2010

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.

Braun J.,Rheumazentrum Ruhrgebiet
Clinical and Experimental Rheumatology | Year: 2012

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.

Braun A.,Rheumazentrum Ruhrgebiet | Saracbasi E.,Rheumazentrum Ruhrgebiet | Grifka J.,Klinik und Poliklinik fur Orthopadie | Schnitker J.,Dr. Jorg Schnitker GmbH | Braun J.,Rheumazentrum Ruhrgebiet
Annals of the Rheumatic Diseases | Year: 2011

Background: The value of clinical items defi ning infl ammatory 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 &λε;35 years, improvement by exercise, improvement with non-steroidal anti-infl ammatory drugs, waking up in the second half of the night and alternating buttock pain were identifi ed as most relevant for diagnosing axial SpA by multiple regression analysis. Differences between AS and nrSpA were detected. No single item was predictive, but &γε;3 items proved useful for good sensitivity and specifi city 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.

Kiltz U.,Rheumazentrum Ruhrgebiet | Heldmann F.,Rheumazentrum Ruhrgebiet | Baraliakos X.,Rheumazentrum Ruhrgebiet | Braun J.,Rheumazentrum Ruhrgebiet
Current Opinion in Rheumatology | Year: 2012

Purpose of Review: Axial spondyloarthritis (SpA)-including ankylosing spondylitis (AS)-is a frequent chronic inflammatory disease that affects mainly the axial skeleton. There is evidence that NSAIDs and tumor necrosis factor (TNF) α blockers are efficacious, but not all patients achieve remission or a major clinical response. A variety of new drug classes have been investigated during the last years for the treatment of patients with AS in whom TNF blockers have failed or are contraindicated. Recent Findings: Data for abatacept, anakinra, apremilast, bisphosphonates, rituximab, secukinumab, sulfasalazine, thalidomide and tocilizumab were found. All studies had problems with design and methodology. Summary: Although some trends for efficacy were seen, there is at present insufficient evidence to support a recommendation for any of these compounds. So far, none of these new drugs has been shown to reach response rates compared to TNF-blockers. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

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