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1.
Désirée M van der Heijde Dennis A Revicki Katherine L Gooch Robert L Wong Hartmut Kupper Neesha Harnam Chris Thompson Joachim Sieper 《Arthritis research & therapy》2009,11(4):R124-12
Introduction
We evaluated the three-year impact of adalimumab on patient-reported physical function and health-related quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS). 相似文献2.
Martin Rudwaleit Filip Van den Bosch Martina Kron Sonja Kary Hartmut Kupper 《Arthritis research & therapy》2010,12(3):R117
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). 相似文献3.
Fiona Maas Anneke Spoorenberg Elisabeth Brouwer Reinhard Bos Monique Efde Rizwana N. Chaudhry Nic J. G. M. Veeger Peter M. A. van Ooijen Rinze Wolf Hendrika Bootsma Eveline van der Veer Suzanne Arends 《PloS one》2015,10(4)
Objectives
To evaluate spinal radiographic damage over time and to explore the associations of radiographic progression with patient characteristics and clinical assessments including disease activity in ankylosing spondylitis (AS) patients treated with tumor necrosis factor-alpha (TNF-α) blocking therapy in daily clinical practice.Methods
Consecutive outpatients from the Groningen Leeuwarden AS (GLAS) cohort were included based on the availability of cervical and lumbar radiographs before start of TNF-α blocking therapy and after 2, 4, and/or 6 years of follow-up. Clinical data were assessed at the same time points. Radiographs were scored by two independent readers using the modified Stoke AS Spine Score (mSASSS). Spinal radiographic progression in relation to clinical assessments was analyzed using generalized estimating equations.Results
176 AS patients were included, 58% had syndesmophytes at baseline. Median mSASSS increased significantly from 10.7 (IQR: 4.6–24.0) at baseline to 14.8 (IQR: 7.9–32.8) at 6 years. At the group level, spinal radiographic progression was linear with a mean progression rate of 1.3 mSASSS units per 2 years. Both spinal radiographic damage at baseline and radiographic progression were highly variable between AS patients. Male gender, older age, longer disease duration, higher BMI, longer smoking duration, high CRP, and high ASDAS were significantly associated with syndesmophytes at baseline. Significantly more radiographic progression was seen in patients with versus without syndesmophytes (2.0 vs. 0.5 mSASSS units per 2 years) and in patients >40 versus ≤40 years of age (1.8 vs. 0.7 mSASSS units per 2 years). No longitudinal associations between radiographic progression and clinical assessments were found.Conclusions
This prospective longitudinal observational cohort study in daily clinical practice shows overall slow and linear spinal radiographic progression in AS patients treated with TNF-α blocking therapy. At the individual level, progression was highly variable. Patients with syndesmophytes at baseline showed a 4-fold higher radiographic progression rate than patients without syndesmophytes. 相似文献4.
Dafna D Gladman Philip J Mease Ernest HS Choy Christopher T Ritchlin Renee J Perdok Eric H Sasso 《Arthritis research & therapy》2010,12(3):R113
Introduction
To identify independent predictors of radiographic progression in psoriatic arthritis (PsA) for patients treated with adalimumab or placebo in the Adalimumab Effectiveness in PsA Trial (ADEPT). 相似文献5.
Gerd Horneff Sigrid Fitter Ivan Foeldvari Kirsten Minden Jasmin Kuemmerle-Deschner Nicolay Tzaribacev Angelika Thon Michael Borte Gerd Ganser Rolf Trauzeddel Hans-Iko Huppertz 《Arthritis research & therapy》2012,14(5):1-12
Introduction
While adalimumab is licensed for ankylosing spondylitis (AS), open uncontrolled studies suggest therapeutic efficacy of TNF-inhibitors in juvenile onset AS (JoAS).Methods
A total of 32 patients aged 12 to 17 years with severe, active and refractory JoAS were enrolled in a multicenter, randomized, double-blind, placebo-controlled parallel study of 12 weeks, followed by open-label adalimumab until week 24 for all patients. ASAS40 was used as the primary, and ASAS20, PedACR and single items were used as the secondary outcome measures for the intention to treat population.Results
A total of 17 patients were randomized to receive adalimumab 40 mg/2 weeks and 15 patients received placebo. Two patients (one of each group) discontinued prematurely due to insufficient efficacy and were labeled as non-responders. In the double-blind part, more patients on adalimumab achieved an ASAS40 at week 4 (41%), week 8 (53%) and week 12 (53%) than on placebo (20%, 33%, 33%), while differences at week 8 only reached borderline significance (P = 0.05). Also, at 4, 8 and 12 weeks ASAS20/PedACR30/70 response rates were higher in the adalimumab group (53%/53%/29%; 59%/76%/41%; 53%/65%/53%) compared to placebo (27%/27%/7%; 27%/33%/13%; 33%/40%/27%). In the adalimumab group a significant decrease of all disease activity parameters was noted at week 12 and was even more pronounced at week 24. At week 12 the Bath Ankylosing Spondylitis Disease activity spinal inflammation score decreased by 65% (P <0.001), the back pain score decreased by 50% (P <0.005), the Bath AS Functional Index (BASFI) score decreased by 47% (P <0.02), while the Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) score improved by 65% (P <0.005). ANCOVA analysis demonstrated superiority of adalimumab over placebo for the physician global assessment of disease activity, parents' global assessment of subject's overall well-being, active joint count (all P <0.05) and erythrocyte sedimentation rate (ESR) (P <0.01). During the 12-week controlled phase, 29 AEs occurred in 10 patients on placebo compared to 27 AEs in 11 patients on adalimumab. Injection site reactions were the most common adverse events. There were 17 various infections occurring in the double-blind phase, 8 on placebo, 9 on adalimumab and a further 19 in the open label period.Conclusions
Adalimumab was well tolerated and highly effective in a double-blind randomized trial in patients with JoAS. Treatment effects rapidly occurred and persisted for at least 24 weeks of treatment.Trial registration
EudraCT 2007-003358-27. 相似文献6.
Martin Rudwaleit Pascal Claudepierre Martina Kron Sonja Kary Robert Wong Hartmut Kupper 《Arthritis research & therapy》2010,12(2):R43
Introduction
The purpose of this study was to investigate the effectiveness of adalimumab in enthesitis and peripheral arthritis in patients with ankylosing spondylitis (AS).Methods
Adults with active AS (Bath ankylosing spondylitis disease activity index [BASDAI] ≥ 4) received adalimumab 40 mg every other week with standard antirheumatic therapies in a 12-week, open-label study. Effectiveness in enthesitis was assessed using the Maastricht ankylosing spondylitis enthesitis score (MASES, 0-13) and by examining the plantar fascia in patients with enthesitis (≥ 1 inflamed enthesis) at baseline; effectiveness in peripheral arthritis was evaluated using tender and swollen joint counts (TJC, 0-46; SJC, 0-44) in patients with peripheral arthritis (≥ 1 swollen joint) at baseline. Overall effectiveness measures included Assessment of SpondyloArthritis International Society 20% response (ASAS20).Results
Of 1,250 patients enrolled, 686 had enthesitis and 281 had peripheral arthritis. In 667 patients with MASES ≥ 1 at baseline, the median MASES was reduced from 5 at baseline to 1 at week 12. At week 12, inflammation of the plantar fascia ceased in 122 of 173 patients with inflammation at baseline. The median TJC in 281 patients with SJC ≥ 1 at baseline was reduced from 5 at baseline to 1 at week 12; the median SJC improved from 2 to 0. ASAS20 responses were achieved by 70.5% of 457 patients with no enthesitis and no arthritis; 71.0% of 512 patients with only enthesitis; 68.0% of 107 patients with only arthritis; and 66.7% of 174 patients with both.Conclusions
Treatment with adalimumab improved enthesitis and peripheral arthritis in patients with active AS.Trial registration
ClinicalTrials.gov . NCT00478660相似文献7.
Ann W Morgan James I Robinson Philip G Conaghan Stephen G Martin Elizabeth MA Hensor Michael D Morgan Lori Steiner Henry A Erlich Hock-Chye Gooi Anne Barton Jane Worthington Paul Emery 《Arthritis research & therapy》2010,12(2):1-10
Introduction
The purpose of this study was to investigate the effectiveness of adalimumab in enthesitis and peripheral arthritis in patients with ankylosing spondylitis (AS).Methods
Adults with active AS (Bath ankylosing spondylitis disease activity index [BASDAI] ≥ 4) received adalimumab 40 mg every other week with standard antirheumatic therapies in a 12-week, open-label study. Effectiveness in enthesitis was assessed using the Maastricht ankylosing spondylitis enthesitis score (MASES, 0-13) and by examining the plantar fascia in patients with enthesitis (≥ 1 inflamed enthesis) at baseline; effectiveness in peripheral arthritis was evaluated using tender and swollen joint counts (TJC, 0-46; SJC, 0-44) in patients with peripheral arthritis (≥ 1 swollen joint) at baseline. Overall effectiveness measures included Assessment of SpondyloArthritis International Society 20% response (ASAS20).Results
Of 1,250 patients enrolled, 686 had enthesitis and 281 had peripheral arthritis. In 667 patients with MASES ≥ 1 at baseline, the median MASES was reduced from 5 at baseline to 1 at week 12. At week 12, inflammation of the plantar fascia ceased in 122 of 173 patients with inflammation at baseline. The median TJC in 281 patients with SJC ≥ 1 at baseline was reduced from 5 at baseline to 1 at week 12; the median SJC improved from 2 to 0. ASAS20 responses were achieved by 70.5% of 457 patients with no enthesitis and no arthritis; 71.0% of 512 patients with only enthesitis; 68.0% of 107 patients with only arthritis; and 66.7% of 174 patients with both.Conclusions
Treatment with adalimumab improved enthesitis and peripheral arthritis in patients with active AS.Trial registration
ClinicalTrials.gov NCT00478660. 相似文献8.
Incidence and predictors of morphometric vertebral fractures in patients with ankylosing spondylitis
Kwi Young Kang In Je Kim Seung Min Jung Seung-Ki Kwok Ji Hyeon Ju Kyung-Su Park Yeon Sik Hong Sung-Hwan Park 《Arthritis research & therapy》2014,16(3):R124
Introduction
Ankylosing spondylitis (AS) is associated with an increased incidence of vertebral fractures (VFs); however the actual incidence and predictors of morphometric VFs are unknown. The present study examined the incidence and predictors of new VFs in a large AS cohort.Methods
In total, 298 AS patients who fulfilled the modified New York criteria were enrolled and spinal radiographs were evaluated biennially. Clinical and laboratory data and radiographic progression were assessed according to the Bath AS Disease Activity Index, erythrocyte sedimentation rate, C-reactive protein (CRP), and the Stoke AS spine score (SASSS). VF was defined according to the Genant criteria. The incidence of VFs at 2 and 4 years was evaluated using the Kaplan-Meier method. The age-specific standardized prevalence ratio (SPR) for AS patients in comparison with the general population was calculated.Results
Of 298 patients, 31 (10.8%) had previous VFs at baseline. A total of 30 new VFs occurred in 26 patients over 4 years. The incidence of morphometric VFs was 4.7% at 2 years and 13.6% at 4 years. Multivariate logistic regression analysis showed that previous VFs at baseline and increased CRP levels at 2 years were predictors of new VFs (odds ratio (OR) =12.8, 95% confidence interval (CI) = 3.6-45.3 and OR = 5.4, 95% CI = 1.4–15.9). The age-specific specific standardized prevalence ratio of morphometric VFs in AS was 3.3 (95% CI 2.1–4.5).Conclusions
The incidence of morphometric VFs increased in AS. Previous VFs and increased CRP levels predicted future VFs. Further studies are needed to identify the effects of treatment interventions on the prevention of new VFs. 相似文献9.
Vappu Rantalaiho Markku Korpela Leena Laasonen Hannu Kautiainen Salme Järvenpää Pekka Hannonen Marjatta Leirisalo-Repo Harri Blåfield Kari Puolakka Anna Karjalainen Timo Möttönen the FIN-RACo Trial Group 《Arthritis research & therapy》2010,12(3):R122
Introduction
Early treatment of rheumatoid arthritis (RA) has been shown to retard the development of joint damage for a period of up to 5 years. The aim of this study was to evaluate the radiologic progression beyond that time in patients with early RA initially treated with a combination of three disease-modifying antirheumatic drugs (DMARDs) or a single DMARD. 相似文献10.
Appel H Janssen L Listing J Heydrich R Rudwaleit M Sieper J 《Arthritis research & therapy》2008,10(5):R125
Introduction
Recent data about radiographic progression during treatment with tumor necrosis factor-alpha (TNF-α) blocker agents in patients with ankylosing spondylitis (AS) have prompted an intensive discussion about the link between inflammation/bone destruction and new bone formation and the order of events. Therefore, we analysed parameters of cartilage degradation, neoangiogenesis, and new bone formation in different cohorts of patients with axial spondyloarthritis with and without treatment with TNF-α blocker agents. 相似文献11.
Sofia Ramiro Astrid van Tubergen Carmen Stolwijk Robert Landewé Filip van de Bosch Maxime Dougados Désirée van der Heijde 《Arthritis research & therapy》2013,15(1):R14
Introduction
Radiographic damage is one of the core outcomes in axial SpA and is usually assessed with the modified Stoke Ankylosing Spondylitis (AS) Spine Score (mSASSS). Alternatively, the Radiographic AS Spinal Score (RASSS) is proposed, which includes the lower thoracic vertebrae, under the hypothesis that most progression occurs in these segments. We aimed to compare the mSASSS and RASSS with regard to performance.Methods
Two-yearly spinal radiographs from patients followed in the Outcome in AS International Study (OASIS) were used (scored independently by two readers). A total of 195 patients had at least one radiograph (12-year follow-up) to be included. We assessed the accessibility of vertebral corners (VCs) for scoring, as well as status and 2-year progression scores of both scoring methods. To assess the potential additional value of including the thoracic segment in the score, the relative contribution (in %) to the 2-year total RASSS progression of each spinal segment (cervical, thoracic and lumbar) was determined, and compared to the expected contribution, under the assumption that a balanced segmental progression would occur, proportional to the number of sites per segment.Results
The mSASSS could be scored in a total of 809 radiographs and the RASSS in 78% of these. In 58% of the latter, the score was based on one to two available thoracic VCs scores, and the remaining two to three were imputed because they were missing. There were 520 two-year mSASSS intervals available, and in 63% of them RASSS progression could be assessed. The mean (SD) 2-year interval progression score (330 intervals) was 2.0 (3.6) for the mSASSS and 2.4 (4.4) for the RASSS, yielding a similar effect size (mSASSS 0.57 and RASSS 0.55). Exclusive progression of the thoracic segment occurred in only 5% of the cases. There was no significant difference between the observed (14%) and expected (16%) contribution to progression of the thoracic segment (P = 0.70).Conclusions
The determination of RASSS for radiographic damage of the spine is frequently impossible or strongly influenced by non-contributory imputation. In comparison to the mSASSS, the contribution of thoracic VCs in the RASSS method is negligible, and does not justify the additional scoring efforts. 相似文献12.
Xenofon Baraliakos Hildrun Haibel Claudia Fritz Joachim Listing Frank Heldmann Juergen Braun Joachim Sieper 《Arthritis research & therapy》2013,15(3):R67
Introduction
Data from clinical studies on the long-term efficacy and safety of anti-tumor necrosis factor (TNF)-α therapy in patients with ankylosing spondylitis (AS) are scarce. This is the first report on continuous treatment with the TNFα fusion protein etanercept over seven years (y).Methods
Overall, 26 patients with active AS were initially treated with etanercept 2 × 25 mg s.c./week with no concomitant disease modifying anti-rheumatic drugs (DMARDs) or steroids. The clinical response was assessed by standardized parameters. The primary outcome was the proportion of patients in the Spondyloarthritis International Society (ASAS) partial remission at seven years. AS disease activity scores (ASDAS) for status and improvement were compared to conventional outcome measures.Results
Overall, 21/26 patients (81%) completed two years of treatment and 16/26 patients (62%) completed seven years. In the completer analysis, 31% patients were in ASAS partial remission at seven years, while 44% patients showed an ASDAS inactive disease status. Mean Bath AS activity index (BASDAI) scores, which were elevated at baseline (6.3 ± 0.9), showed constant improvement and remained low: 3.1 ± 2.5 at two years and 2.5 ± 2.2 at seven years, while ASDAS also improved (3.9 ± 0.7 at baseline, 1.8 ± 0.9 at two years, 1.6 ± 0.8 at seven years), all P <0.001. From the 10 dropouts, only 5 patients discontinued treatment due to adverse events. Patients who completed the study had lower baseline Bath AS function index (BASFI) scores vs. patients who discontinued. No other clinical parameter at baseline could predict any long-term outcome.Conclusions
This study confirms the clinical efficacy and safety of etanercept in patients with active AS over seven years of continuous treatment. After seven years, more than half of the initially treated patients remained on anti-TNF therapy, and one-third were in partial remission.Trial Registration
ClinicalTrials.gov: NCT01289743相似文献13.
Franziska G Matzkies Stephan R Targan Dror Berel Carol J Landers John D Reveille Dermot PB McGovern Michael H Weisman 《Arthritis research & therapy》2012,14(6):R261
Introduction
Inflammatory bowel disease (IBD) and ankylosing spondylitis (AS) are similar chronic inflammatory diseases whose definitive etiology is unknown. Following recent clinical and genetic evidence supporting an intertwined pathogenic relationship, we conducted a pilot study to measure fecal calprotectin (fCAL) and IBD-related serologies in AS patients.Methods
Consecutive AS patients were recruited from a long-term prospectively collected longitudinal AS cohort at Cedars-Sinai Medical Center. Controls were recruited from Cedars-Sinai Medical Center employees or spouses of patients with AS. Sera were tested by ELISA for IBD-associated serologies (antineutrophil cytoplasmic antibodies (ANCA), anti-Saccharomyces cerevisiae antibody IgG and IgA, anti-I2, anti-OmpC, and anti-CBir1). The Bath Ankylosing Spondylitis Disease Activity Index, the Bath Ankylosing Spondylitis Functional Index, and the Bath Ankylosing Spondylitis Radiology Index were completed for AS patients.Results
A total of 81 subjects (39 AS patients and 42 controls) were included for analysis. The average age of AS patients was 47 years and the average disease duration was 22 years. AS patients were predominantly male; 76% were HLA-B27-positive. Median fCAL levels were 42 μg/g and 17 μg/g in the AS group and controls, respectively (P < 0.001). When using the manufacturer''s recommended cutoff value for positivity of 50 μg/g, stool samples of 41% of AS patients and 10% of controls were positive for fCAL (P = 0.0016). With the exception of ANCA, there were no significant differences in antibody levels between patients and controls. Median ANCA was 6.9 ELISA units in AS patients and 4.3 ELISA units in the controls. Among AS patients stratified by fCAL level, there were statistically significant differences between patients and controls for multiple IBD-associated antibodies.Conclusion
Calprotectin levels were elevated in 41% of patients with AS with a cutoff value for positivity of 50 μg/g. fCAL-positive AS patients displayed higher medians of most IBD-specific antibodies when compared with healthy controls or fCAL-negative AS patients. Further studies are needed to determine whether fCAL can be used to identify and characterize a subgroup of AS patients whose disease might be driven by subclinical bowel inflammation. 相似文献14.
Gunnhild Berdal Silje Halvorsen Désirée van der Heijde Morten Mowe Hanne Dagfinrud 《Arthritis research & therapy》2012,14(1):R19-10
Introduction
Pulmonary involvement is a known manifestation in patients with ankylosing spondylitis (AS). However, previous studies have been based on small samples and the reported prevalence and associations with typical clinical features vary. The purpose of this study was to compare pulmonary function (PF) in patients with AS and population controls, and to study associations between PF and disease related variables, cardio-respiratory fitness and demographic variables in patients with AS. 相似文献15.
Tamar F Brionez Shervin Assassi John D Reveille Thomas J Learch Laura Diekman Michael M Ward John C Davis Jr Michael H Weisman Perry Nicassio 《Arthritis research & therapy》2009,11(6):R182-9
Introduction
Functional status is an integral component of health-related quality of life in patients with ankylosing spondylitis (AS). The purpose of this study was to investigate the role of psychological variables in self-reported functional limitation in patients with AS, while controlling for demographic and medical variables. 相似文献16.
17.
Valérie Badot Christine Galant Adrien Nzeusseu Toukap Ivan Theate Anne-Lise Maudoux Benoît J Van den Eynde Patrick Durez Frédéric A Houssiau Bernard R Lauwerys 《Arthritis research & therapy》2009,11(2):R57-13
Introduction
To identify markers and mechanisms of resistance to adalimumab therapy, we studied global gene expression profiles in synovial tissue specimens obtained from severe rheumatoid arthritis (RA) patients before and after initiation of treatment. 相似文献18.
Virginia Pascual-Ramos Irazú Contreras-Yá?ez Antonio R Villa Javier Cabiedes Marina Rull-Gabayet 《Arthritis research & therapy》2009,11(1):R26
Introduction
Aggressive treatment with disease-modifying antirheumatic drugs (DMARDs) plays a major role in improving early rheumatoid arthritis (RA) patient outcomes. Persistence and adherence with medication occurs variably (20% to 70%). The objectives of the study were to determine medication persistence (MP) in early RA patients over 13 consecutive visits each 2 months apart, to investigate the relationship between MP and disease activity, disability and structural damage, and to identify baseline prognosticators. 相似文献19.
Jorit JL Meesters Ann Bremander Stefan Bergman Ingemar F Petersson Aleksandra Turkiewicz Martin Englund 《Arthritis research & therapy》2014,16(5)
Introduction
Depression is frequent in ankylosing spondylitis (AS) patients. However, epidemiological data about the potential increase in risk are lacking. This study compares the rate of doctor-diagnosed depression in a well defined cohort of AS patients to the general population seeking care.Methods
The Skåne Healthcare Register comprises healthcare data of each resident in Region Skåne, Sweden (population 1.2 million), including ICD-10 diagnoses. Using physician coded consultation data from years 1999 to 2011, we calculated depression consultation rates for all AS patients. We obtained standardized depression-rate ratios by dividing the observed depression rate in AS patients by the expected rate based on the corresponding age- and sex-specific rates of depression in the general population seeking care. A ratio >1 equals a higher rate of depression among AS patients.Results
The AS cohort consisted of 1738 subjects (65% men) with a mean age of 54 years. The reference population consisted of 967,012 subjects. During the 13-year observation period 10% (n = 172) of the AS cohort had a doctor-diagnosed depression compared to 6% (n = 105) to be expected. The standardized estimate of depression-rate ratio was 1.81 (95% confidence interval 1.44 to 2.24) in women men and 1.49 (1.20 to 1.89) in men.Conclusions
The rate of doctor-diagnosed depression is increased about 80% in female and 50% in male AS patients. Future challenges are to timely identify and treat the AS patients who suffer from depression. 相似文献20.
Sara Shimoni Iris Bar Valery Meledin Estela Derazne Gera Gandelman Jacob George 《PloS one》2016,11(2)