Campus Benjamin Franklin Hospital

Berlin, Germany

Campus Benjamin Franklin Hospital

Berlin, Germany

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Haibel H.,Campus Benjamin Franklin Hospital | Listing J.,German Rheumatism Research Center | Callhoff J.,German Rheumatism Research Center | Sieper J.,Campus Benjamin Franklin Hospital | Sieper J.,German Rheumatism Research Center
Annals of the Rheumatic Diseases | Year: 2014

Background The efficacy of oral prednisolone in patients with active ankylosing spondylitis (AS) has not been studied to date. Methods In this double-blind, randomised, placebo-controlled trial, patients with AS with active disease despite taking non-steroidal antirheumatic drugs were randomised to three groups in which they were either treated with 20 mg (n=13) or 50 mg (n=12) of prednisolone, or placebo (n=14), administered orally every day for a total of 2 weeks. The primary endpoint was defined as a 50% improvement of the Bath AS Disease Activity Index (BASDAI) at week 2. Results The primary endpoint was reached in 33% and 27% of the patients treated with 50 and 20 mg of prednisolone, respectively, versus only 8% on placebo (p=0.16 and p=0.30). However, the mean improvement of BASDAI score was significantly higher in the 50 mg prednisolone compared to the placebo group (2.39±0.5 vs 0.66±0.49, p=0.03), while there was only a small change in the 20 mg group (1.19±0.53; p=0.41). The results for other outcome parameters were similar. Conclusions Oral prednisolone 50 mg per day, but not low dose prednisolone, showed a short-term response that was significantly higher than placebo. The clinical significance and the duration of this effect warrant further study.


Rudwaleit M.,Campus Benjamin Franklin Hospital | Van den Bosch F.,Ghent University | Kron M.,Abbott Laboratories | Kary S.,Abbott Laboratories | Kupper H.,Abbott Laboratories
Arthritis Research and Therapy | Year: 2010

Introduction: Tumor necrosis factor (TNF) antagonists reduce the signs and symptoms of spondyloarthritides, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Our objective was to evaluate the effectiveness and safety of adalimumab, 40 mg every other week, for patients with AS or PsA and prior treatment with infliximab (IFX) and/or etanercept (ETN).Methods: Both trials were 12-week, open-label studies with an optional extension period up to week 20. Patients were stratified by history of anti-TNF treatment, prior anti-TNF therapy received (IFX, ETN, or both), and reason for discontinuation of prior TNF antagonist. ETN was discontinued ≥ 3 weeks, and IFX was discontinued ≥ 2 months before the first adalimumab administration. Effectiveness at week 12 was evaluated by using observed standard-outcome measurements for AS and PsA.Results: At week 12 of adalimumab treatment, Bath Ankylosing Spondylitis Disease Activity Index 50 responses were achieved by 40.8% of 326 patients with AS who had received prior anti-TNF therapy and by 63.0% of 924 patients with AS who were naive to TNF antagonist. Observed response rates were generally greater for patients who discontinued the prior anti-TNF therapy because of loss of response or intolerance than for patients who discontinued because of lack of response. Median changes in swollen-joint count and in enthesitis score were similar in patients with and without prior TNF-antagonist treatment. Modified PsA response criteria were fulfilled by 71.2% of 66 patients with PsA, with prior exposure to TNF antagonists, and by 78.8% of 376 patients with no history of anti-TNF therapy. The percentages of patients with PsA attaining a Physician's Global Assessment of psoriasis of "Clear/Almost clear" increased from 33.3% to 61.0% for patients with prior IFX and/or ETN treatment and from 34.6% to 69.7% for patients without anti-TNF therapy. The median change in the Nail Psoriasis Severity Index was -6 for both groups. In both studies, patterns of adverse events were similar for patients with and without prior anti-TNF therapy and were consistent with the known safety profile of adalimumab.Conclusions: Patients with AS or PsA previously treated with IFX and/or ETN experienced clinically relevant improvements of their diseases after 12 weeks of adalimumab.Trial registrations: ClinicalTrials.gov NCT00478660 and NCT00235885. © 2010 Rudwaleit et al.; licensee BioMed Central Ltd.


Braun J.,Ruhr University Bochum | Rudwaleit M.,Campus Benjamin Franklin Hospital | Kary S.,Abbott Laboratories | Kron M.,Abbott Laboratories | And 2 more authors.
Rheumatology | Year: 2010

Objectives: To compare the clinical manifestations of spinal disease, peripheral arthritis and enthesitis, and to evaluate the effectiveness of adalimumab in a large cohort of patients with AS in relation to the presence or absence of psoriasis. Methods: Patients aged <18 years with active AS were enrolled in an open-label study of adalimumab 40 mg every other week. Clinical symptoms were measured at baseline and Week 12 using standard assessment criteria. Differences between patients with and those without psoriasis were assessed. The relationship between changes in skin and AS symptoms was also analysed. Results: Of 1250 patients with AS who were enrolled in the study, 148 (11.8%) had a history of psoriasis, including 108 patients with current (active) psoriasis at entry. Baseline disease characteristics, including spinal structural damage, peripheral arthritis (≤1 swollen joints) and enthesitis (≤1 inflamed entheses), were similar in both groups. At Week 12, Assessment of SpondyloArthritis international Society 40% response was achieved by 46.7 and 54.7% and Bath AS Disease Activity Index 50% response by 58.6 and 57.0% of patients with and without psoriasis, respectively. Median changes in swollen joint scores and Maastricht AS Enthesitis Scores were similar in both groups. Skin changes during adalimumab treatment in AS patients with a history of psoriasis did not correlate with changes in AS symptoms. Conclusions: The presence of psoriasis had no influence on the other clinical manifestations of patients with AS. Treatment with adalimumab markedly improved axial disease, peripheral arthritis and enthesitis, regardless of history of psoriasis. © The Author 2010.


PubMed | Campus Benjamin Franklin Hospital
Type: Clinical Trial | Journal: Arthritis research & therapy | Year: 2010

Tumor necrosis factor (TNF) antagonists reduce the signs and symptoms of spondyloarthritides, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Our objective was to evaluate the effectiveness and safety of adalimumab, 40 mg every other week, for patients with AS or PsA and prior treatment with infliximab (IFX) and/or etanercept (ETN).Both trials were 12-week, open-label studies with an optional extension period up to week 20. Patients were stratified by history of anti-TNF treatment, prior anti-TNF therapy received (IFX, ETN, or both), and reason for discontinuation of prior TNF antagonist. ETN was discontinued>or=3 weeks, and IFX was discontinued>or=2 months before the first adalimumab administration. Effectiveness at week 12 was evaluated by using observed standard-outcome measurements for AS and PsA.At week 12 of adalimumab treatment, Bath Ankylosing Spondylitis Disease Activity Index 50 responses were achieved by 40.8% of 326 patients with AS who had received prior anti-TNF therapy and by 63.0% of 924 patients with AS who were naive to TNF antagonist. Observed response rates were generally greater for patients who discontinued the prior anti-TNF therapy because of loss of response or intolerance than for patients who discontinued because of lack of response. Median changes in swollen-joint count and in enthesitis score were similar in patients with and without prior TNF-antagonist treatment. Modified PsA response criteria were fulfilled by 71.2% of 66 patients with PsA, with prior exposure to TNF antagonists, and by 78.8% of 376 patients with no history of anti-TNF therapy. The percentages of patients with PsA attaining a Physicians Global Assessment of psoriasis of Clear/Almost clear increased from 33.3% to 61.0% for patients with prior IFX and/or ETN treatment and from 34.6% to 69.7% for patients without anti-TNF therapy. The median change in the Nail Psoriasis Severity Index was -6 for both groups. In both studies, patterns of adverse events were similar for patients with and without prior anti-TNF therapy and were consistent with the known safety profile of adalimumab.Patients with AS or PsA previously treated with IFX and/or ETN experienced clinically relevant improvements of their diseases after 12 weeks of adalimumab.ClinicalTrials.gov NCT00478660 and NCT00235885.

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