57 results on '"Désirée, Van Der Heijde"'
Search Results
2. Baseline and 2-year differences in spinal symptoms and spinal and hip mobility in early axial spondyloarthritis and non-axial spondyloarthritis chronic back pain patients
- Author
-
Sofia Ramiro, Désirée van der Heijde, Roberta Ramonda, Floris A van Gaalen, Mary Lucy Marques, Sofia Exarchou, Miranda van Lunteren, Camilla Fongen, Marleen van de Sande, and Ana Bento da Silva
- Subjects
Medicine - Abstract
Objective To compare spinal symptoms and spinal/hip mobility at baseline and 2 years in early axial spondyloarthritis (axSpA) and non-axSpA chronic back pain (BP) patients.Methods Baseline and 2 years data of the SPondyloarthritis Caught Early cohort were analysed. Outcomes assessed: overall BP, BP at night, morning stiffness (MS) intensity, MS duration, occiput-to-wall distance (OWD), cervical rotation, chest expansion, lateral spinal flexion (LSF), modified Schober test (mSchober), intermalleolar distance (IMD) and Bath Ankylosing Spondylitis Metrology Index (BASMI). Linear or zero-inflated negative binomial regression was used to compare 2 years outcomes between groups (adjusting for baseline value, sex, age and use of non-steroidal anti-inflammatory drugs).Results There were 294 axSpA and 123 non-axSpA patients (mean symptom duration: 13 months). At baseline, non-axSpA patients had worse symptoms and mobility, except OWD (eg, mean(SD): BP at night 3.6 (2.9) axSpA vs 4.6 (2.7) non-axSpA; OWD 0.5 (1.2) vs 0.1 (0.7)). After 2 years, all symptoms and cervical rotation significantly improved in both groups, but LSF and mSchober only in axSpA. In multivariable analyses, axSpA was associated with larger improvements in BP at night (β (95% CI): −0.85 (−1.47; −0.23)), mSchober (0.26 (0.03; 0.50)), IMD (4.86 (1.93; 7.80)) and BASMI (−0.24 (−0.41; −0.08)), and with lower likelihood of a normal OWD (OR (95% CI): 0.09 (0.01; 0.83)).Conclusion Over 2 years, all spinal symptoms and some mobility measures improved in both groups, but impairments remained prevalent (particularly in non-axSpA). Nevertheless, axSpA was associated with larger improvements in BP at night, mSchober, IMD and BASMI, but with more OWD impairment.
- Published
- 2024
- Full Text
- View/download PDF
3. Change in different classes of chronic back pain suspicious of axial spondyloarthritis: a latent transition analysis of the SPACE cohort
- Author
-
Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Roberta Ramonda, Alexandre Sepriano, Manouk de Hooge, Floris A van Gaalen, Karen Minde Fagerli, Sofia Exarchou, Caroline Bastiaenen, Miranda van Lunteren, Philipp Bosch, Mary-Lucy Marques, and Liese de Bruin
- Subjects
Medicine - Abstract
Objectives To follow up four previously identified classes ‘pure axial spondyloarthritis’ (axSpA) (‘axial’), ‘axSpA with peripheral signs’ (‘inflammatory back pain+peripheral’), ‘axSpA at risk’ and ‘no spondyloarthritis’ (‘no SpA’). They reflect the expert-opinion-free construct or ‘Gestalt’ of chronic back pain suspicious of axSpA. The aim was to assess participants’ transitions between these classes over time.Methods Participants with chronic back pain of ≤2 years duration, suspicious of axSpA from the SPondyloArthritis Caught Early cohort were analysed. Latent class (LCA) and latent transition analysis (LTA) using clinical, laboratory and imaging data at baseline and 2 years were calculated. Conditional and marginal probabilities were obtained, reflecting the probability of a spondyloarthritis feature in a class and the probability of the participant’s class membership, respectively. Transitional probabilities were extracted revealing potential switches across classes. The analyses were performed in all participants using imputations for missing data and in participants with full data at baseline and 2 years.Results Baseline and 2 years LCA models were constructed for 702 participants, resulting in the same four-class model as previously described. LTA revealed only a 3% transition from the ‘no SpA’ to the ‘at-risk’ class from baseline to 2 years with all other participants remaining in their initially assigned class. Sensitivity analysis on 384 participants with complete data at both baseline and 2 years showed similar results, underlining the model’s robustness.Conclusions Transitions between the four classes over 2 years were basically inexistent, highlighting the unlikelihood of developing new class-defining features of axSpA after an initial clinical workup.
- Published
- 2024
- Full Text
- View/download PDF
4. Agreement between patient-reported flares and clinically significant flare status in patients with rheumatoid arthritis in sustained remission: data from the ARCTIC REWIND trials
- Author
-
Désirée van der Heijde, Gunnstein Bakland, Åse Lexberg, Lena Bugge Nordberg, Siri Lillegraven, Anna-Birgitte Aga, Joseph Sexton, Till Uhlig, Espen A Haavardsholm, Karen Holten, Daniel H Solomon, Ellen Moholt, Hallvard Fremstad, Hilde Haukeland, Nina Paulshus Sundlisæter, Cristina Spada, Kaja E Kjørholt, Christian A Høili, Tor Magne Madland, Inger Johanne Widding Hansen, Inger Myrnes Hansen, and Maud-Kristine Aga Ljoså
- Subjects
Medicine - Abstract
Objectives To explore the agreement between patient-reported flare status and clinically significant flare status in patients with rheumatoid arthritis (RA) in sustained remission.Method Patients with RA in remission for ≥12 months on stable treatment were included in the ARCTIC REWIND tapering trials and pooled 12-month data used in current analyses. Patient-reported flare status was assessed according to the Outcome Measures in Rheumatology flare questionnaire; ‘Are you having a flare of your RA at this time?’ (yes/no). A clinically significant flare was defined as a combination of Disease Activity Score (DAS) >1.6, increase in DAS of ≥0.6 and 2 swollen joints, or the rheumatologist and patient agreed that a clinically significant flare had occurred. Agreement coefficient, sensitivity, specificity and predictive values of patient-reported flare status with regard to clinically significant flare status were determined.Results Of 248 patients, 64% were women, age 56.1 (11.8) years, disease duration 4.1 (2.8–7.4) years, DAS 0.8 (0.3). 35% of patients reported a flare at least once, clinically significant flares were recorded in 21%. 48/53 clinically significant flares (91%) led to an intensification of disease-modifying antirheumatic drugss. In 621/682 (91%) visits, patient-reported and clinically significant flare status were in agreement, agreement coefficient 0.89. Sensitivity and specificity were both 91%, positive predictive value of patient-reported flare status 46% and negative predictive value 99%.Conclusion Among patients in sustained remission, patient-reported flare status was accurate in ruling out a clinically significant flare. About half of the patient-reported flares were assessed to be clinically significant. These findings support a potential for using patient-reported flare status in remote monitoring of patients with RA in sustained remission.
- Published
- 2024
- Full Text
- View/download PDF
5. Inflammation in the posterior elements, in particular the facet joint and facet joint ankylosis over 2-year follow-up in radiographic axial spondyloarthritis
- Author
-
Sofia Ramiro, Désirée van der Heijde, Jürgen Braun, Alexandre Sepriano, Floris A van Gaalen, and Roos Stal
- Subjects
Medicine - Abstract
Objectives To assess the association of posterior element (PE) and facet joint (FJ) inflammation with subsequent new FJ ankylosis (FJA) on MRI, in patients with radiographic axial spondyloarthritis (r-axSpA).Methods Patients from the Sensitive Imaging in Ankylosing Spondylitis cohort, inclusion criteria r-axSpA and ≥1 radiographic spinal syndesmophyte, were studied. MRI of the full spinal was performed at baseline, 1 and 2 years. PE/FJ inflammatory lesions and FJA were assessed per vertebral unit (VU) level by three readers. With multilevel time-lagged autoregressive generalised estimated equations, the association between PE/FJ inflammation and the subsequent development of FJA was investigated, taking the reader and VU levels into account.Results Out of the 58 patients with at least 2 reader scores available, mean age 49 (SD 10) years, 84% men, 59% had baseline PE inflammation, 24% had FJ inflammation and 26% had FJA. PE inflammation was more prevalent in the lower thoracic spine and FJ inflammation in the upper thoracic spine. VU with PE or FJ inflammation showed subsequent new FJA in two and one VU levels, respectively. The probability of developing FJA doubled with prior FJ inflammation. In multilevel analysis, FJ inflammation was associated with subsequent FJA (OR=3.8, 95% CI: 1.5 to 9.8), while no association was found between PE inflammation and new FJA (OR=1.2 (0.6–2.4)).Conclusions FJ inflammation is rare in severe r-axSpA, but when present, the likelihood of developing subsequent FJA is over three times higher compared with FJ without inflammation. This finding contributes to the understanding of the relationship between inflammation and ankylosis at the same anatomical location in patients with axSpA.
- Published
- 2024
- Full Text
- View/download PDF
6. Remission definitions guiding immunosuppressive therapy in rheumatoid arthritis: which is best fitted for the purpose?
- Author
-
Désirée van der Heijde, Laure Gossec, Johannes W G Jacobs, Paco M J Welsing, José António Pereira Da Silva, Ricardo J O Ferreira, and Cátia Duarte
- Subjects
Medicine - Abstract
Objective To assess which definition of remission best predicts good radiographic outcome (GRO) and good functional outcome (GFO) in rheumatoid arthritis, focusing the updated American College of Rheumatology/European Alliance of Associations for Rheumatology criteria.Material and methods Meta-analyses of individual patient data (IPD) from randomised controlled trials (RCTs). Six definitions of remission were considered: (1) Boolean with Patient Global Assessment (PGA)≤1 (Boolean); (2) Simplified Disease Activity Index (SDAI)≤3.3; (3) Clinical Disease Activity Index (CDAI)≤2.8; (4) Boolean with PGA≤2 (Updated-Boolean); (5) Boolean with Physician Global Assessment (PhGA≤1) replacing PGA (Boolean-PhGA) and (6) Boolean excluding PGA (3VBoolean). GRO was defined as a worsening ≤0.5 units in radiographic score and GFO as a no worsening in Health Assessment Questionnaire (HAQ), that is, ∆HAQ-DI≤0.0 units. Relationships between each remission definition at 6 and/or 12 months and GRO and GFO during the second year were analysed. Pooled probabilities for each outcome for each definition and their predictive accuracy were estimated.Results IPD from eight RCTs (n=4423) were analysed. Boolean, SDAI, CDAI, Updated-Boolean, Boolean-PhGA and 3VBoolean were achieved by 24%, 27%, 28%, 32%, 33% and 43% of all patients, respectively. GRO among patients achieving remission ranged from 82.4% (3VBoolean) to 83.9% (SDAI). 3VBoolean showed the highest predictive accuracy for GRO: 51.1% versus 38.8% (Boolean) and 44.1% (Updated-Boolean). The relative risk of GFO ranged from 1.16 (Boolean) to 1.05 (3VBoolean). However, the proportion of GFO correctly predicted was highest for the 3VBoolean (50.3%) and lowest for the Boolean (43.8%).Conclusion 3VBoolean definition provided the most accurate prediction of GRO and GFO, avoiding the risk of overtreatment in a substantial proportion of patients without increment in radiographic damage progression, supporting the proposal that 3VBoolean remission is preferable to guide immunosuppressive treatment. The patient’s perspective, which must remain central, is best served by an additional patient-oriented target: a dual-target approach.
- Published
- 2024
- Full Text
- View/download PDF
7. Comparison of the ASAS Health Index in patients classified as radiographic axial spondyloarthritis (axSpA) or non-radiographic axSpA in the ASAS Health Index international validation study
- Author
-
Désirée van der Heijde, Annelies Boonen, Jürgen Braun, Uta Kiltz, Yu Heng Kwan, Warren Fong, and Ting Hui Woon
- Subjects
Medicine - Abstract
Objectives To determine if there were differences in the Assessment of SpondyloArthritis international Society Health Index (ASAS HI) scores between patients classified as radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axSpA (nr-axSpA), and to identify factors associated with higher ASAS HI scores in both disease phenotypes.Methods This study was an ancillary analysis of the ASAS HI international validation project performed in 23 countries. Patients were included if they were ≥18 years of age and diagnosed with axSpA. Univariable and multivariable analysis were performed to determine if ASAS HI scores differed between the axSpA phenotypes, and to identify other variables associated with ASAS HI scores. We also tested for potential interactions between the axSpA phenotype and significant variables identified through the multivariable regression.Results A total of 976 patients were included, with 703 having r-axSpA and 273 nr-axSpA. Patients with r-axSpA reported higher (worse) ASAS HI scores compared with those with nr-axSpA (6.8 (4.4) vs 6.0 (4.0), p=0.02), but the axSpA phenotype was not associated with ASAS HI scores in the multivariable regression (β: −0.19, 95% CI: −0.56 to 0.19). Female gender, having worse physical function (Bath Ankylosing Spondylitis Functional Index), disease activity (Ankylosing Spondylitis Disease Activity Score) and anxiety and depressive symptoms (Hospital Anxiety and Depression Scale) were associated with higher ASAS HI scores. No interactions were found to be significant.Conclusion Overall health and functioning are similarly affected in patients with r-axSpA and nr-axSpA. Female patients, having worse physical function, disease activity, anxiety and depressive symptoms were independently associated with higher ASAS HI scores.
- Published
- 2024
- Full Text
- View/download PDF
8. Atlas for the CT Syndesmophyte Score (CTSS) in patients with axial spondyloarthritis
- Author
-
Sofia Ramiro, Désirée van der Heijde, Monique Reijnierse, Torsten Diekhoff, Manouk de Hooge, Floris A van Gaalen, Mary Lucy Marques, and Kay Geert A. Hermann
- Subjects
Medicine - Abstract
Background: The Computed Tomography Syndesmophyte Score (CTSS) was developed as a reliable and sensitive tool to assess syndesmophytes in low-dose CT images of the entire spine in patients with axial spondyloarthritis (axSpA). The original paper provided sparce examples of the CTSS grades.Objectives: Provide an atlas tailored to assist readers in understanding and employing the CTSS method.Methods: In this paper, illustrations of the different grades and views of the CTSS are presented. CTSS is used to measure bone formation in the spine of patients with axial spondyloarthritis (axSpA), in the form of syndesmophytes. In both the sagittal and coronal planes, syndesmophytes can be graded from 0 to 3 over 23 vertebral units starting at C2 and ending at S1. The CTSS ranges from 0 (absence of axSpA-related syndesmophytes) to 552 (total ankylosis of the spine).Results: The current atlas contains low-dose CT images of the spine without lesions (for reference) and all grades of syndesmophytes in different planes used in the CTSS. Examples are arranged per spinal segment (cervical, thoracic and lumbar).Conclusions: These images can be used to assist any reader in the assessment of syndesmophytes on (low-dose) CT in patients with axSpA.
- Published
- 2024
- Full Text
- View/download PDF
9. Impact of disease outcomes on the Assessment of SpondyloArthritis International Society Health Index (ASAS HI): a Bayesian network analysis of the DESIR cohort
- Author
-
Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Maxime Dougados, Annelies Boonen, Jürgen Braun, Uta Kiltz, and Imke Redeker
- Subjects
Medicine - Abstract
Objective The objective of this study is to build a structural model visualising and quantifying the interrelationships of different disease outcomes with the Assessment of SpondyloArthritis International Society Health Index (ASAS HI) in patients with axial spondyloarthritis (axSpA).Methods Cross-sectional data collected at month 72 of the Devenir des Spondylarthropathies Indifferénciées Récentes cohort was analysed. Combining prior knowledge and observed data, probabilistic Bayesian network modelling was used to study how the interplay of different disease outcomes affects the ASAS HI, which measures disease-specific overall functioning and health. Disease outcomes comprised, among others, the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) and the Bath AS Functional Index (BASFI).Results Data of 384 patients were analysed. The obtained structure suggests that ASAS HI is determined by both patient-reported physical function (BASFI) and disease activity (ASDAS). The parameters of the structural model show that an increase of ASDAS or BASFI by 1 unit corresponds to an increase of ASAS HI by 0.70 or 1.25 units, respectively. Moreover, the model suggests that disease activity has an indirect impact on ASAS HI via BASFI. No relationship between spinal mobility or structural damage and ASAS HI was found.Conclusions This is the first structural model developed to better understand the construct and the interplay between clinically relevant outcomes related to ASAS HI in axSpA patients. It shows that disease activity and physical function have a strong impact on ASAS HI, confirming it to be a valid construct of overall functioning and health in axSpA patients.
- Published
- 2023
- Full Text
- View/download PDF
10. Do fatty lesions explain the effect of inflammation on new syndesmophytes in patients with radiographic axial spondyloarthritis? Results from the SIAS cohort and ASSERT trial
- Author
-
Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Xenofon Baraliakos, Monique Reijnierse, Juergen Braun, Pedro M Machado, Alexandre Sepriano, Floris A van Gaalen, Rosaline van den Berg, and Rosalinde Stal
- Subjects
Medicine - Abstract
Objectives To determine how much of the effect of vertebral corner inflammation on development of syndesmophytes is explained by vertebral corner fat deposition.Methods Patients with radiographic axial spondyloarthritis (r-axSpA) from the SIAS (Sensitive Imaging in Ankylosing Spondylitis) cohort and ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial were assessed at T0, T1 (SIAS: 1 year; ASSERT: 24 weeks) and T2 (2 years). Syndesmophytes assessed in each vertebral corner by whole spine low-dose CT (SIAS) or spinal radiographs (ASSERT) at T0 and T2 were considered present if seen by two of two readers. Inflammation (T0) and fat deposition (T0 and T1) on MRI were present if seen by ≥2 of 3 readers (SIAS) or 2 of 2 readers (ASSERT). Vertebral corners showing fat deposition or a syndesmophyte at baseline were ignored. Mediation analysis was applied to determine what proportion of the total effect of inflammation on syndesmophyte formation could be explained via the path of intermediate fat deposition.Results Forty-nine SIAS patients (with 2667 vertebral corners) and 168 ASSERT patients (with 2918 vertebral corners) were analysed. The presence of inflammation at T0 increased the probability of a new syndesmophyte in the same vertebral corner at T2 by 9.3%. Of this total effect, 0.2% (2% (0.2 of 9.3) of the total effect) went via intermediate new fat deposition. In ASSERT, the total effect was 7.3%, of which 0.8% (10% of the total effect) went via new fat deposition.Conclusion In r-axSpA, vertebral corner inflammation may lead to syndesmophyte formation but in a minority of cases via visible fat deposition.
- Published
- 2023
- Full Text
- View/download PDF
11. Robust analyses for radiographic progression in rheumatoid arthritis
- Author
-
Robert Landewé, Désirée van der Heijde, Yun-fei Chen, Luna Sun, and Mo Daojun
- Subjects
Medicine - Abstract
Demonstrating inhibition of the structural damage to joints as a statistically significant difference in radiographic progression as measured by the van der Heijde modified Total Sharp Score (mTSS) is a common objective in trials for rheumatoid arthritis treatments. The frequently used analysis of the covariance model with missing data imputed using linear extrapolation (analyses of covariance, ANCOVA+LE) may not be ideal for long-term extension studies or for paediatric studies. The random coefficient (RC) model may represent a better alternative.A two-arm (active treatment and placebo) setting with a week 44 study period was considered. RC model, ANCOVA+LE and ANCOVA with last observation carried forward imputation were compared under different scenarios in bias, root mean square error (RMSE), power and type I error rate.The RC model outperformed ANCOVA+LE in metrics measuring bias, RMSE, power and type I error rate under the evaluated scenarios. ANCOVA and RC provide similar performance when there are no missing data. With missing data, RC+observed (OBS) provides similar or better results than ANCOVA+LE in power and bias.Our simulations support that RC is both a more sensitive and a more precise alternative to the commonly used ANCOVA+LE as a primary method for analysing mTSS in long-term extension and paediatric studies with a higher likelihood of missing data. The RC model can provide a reference at time points with missing data by estimating a slope; mTSS change by one unit change in time. ANCOVA+LE is recommended as a sensitivity analysis.
- Published
- 2023
- Full Text
- View/download PDF
12. Good construct validity of the CT Syndesmophyte Score (CTSS) in patients with radiographic axial spondyloarthritis
- Author
-
Sofia Ramiro, Désirée van der Heijde, Xenofon Baraliakos, Monique Reijnierse, Juergen Braun, Floris A van Gaalen, Rosaline van den Berg, and Rosalinde Stal
- Subjects
Medicine - Abstract
Objectives To assess construct validity of the CT Syndesmophyte Score (CTSS) for the measurement of structural spinal damage in patients with radiographic axial spondyloarthritis.Methods Low-dose CT and conventional radiography (CR) were performed at baseline and 2 years. CT was assessed with CTSS by two readers and CR with modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) by three readers. Two hypotheses were tested: (1) syndesmophytes scored with CTSS are also detected with mSASSS at baseline or 2 years later; (2) CTSS is non-inferior to mSASSS in correlations with spinal mobility measures. Presence of a syndesmophyte was determined per reader per corner for all anterior cervical and lumbar corners on CT at baseline and CR at baseline and 2 years. Correlations of CTSS and mSASSS with six spinal/hip mobility measurements plus Bath Ankylosing Spondylitis Metrology Index (BASMI) were tested.Results Data from 48 patients (85% male, 85% HLA-B27+, mean age 48 years) were available for hypothesis 1 and 41/48 were available for hypothesis 2. At baseline, syndesmophytes were scored with CTSS in 348 (reader 1, 38%) and 327 (reader 2, 36%) corners out of 917. Of these, depending on reader pairs, 62%–79% were also seen on CR at baseline or after 2 years. CTSS correlated well (rs0.46–0.73), and with higher correlation coefficients than mSASSS (rs0.34–0.64), with all spinal mobility measures and BASMI.Conclusions The good agreement between syndesmophytes detected by CTSS and mSASSS and the strong correlation of CTSS with spinal mobility support the construct validity of the CTSS.
- Published
- 2023
- Full Text
- View/download PDF
13. Inflammation, bone loss and 2-year bone formation at the same vertebra in axial spondyloarthritis: a multilevel MRI and low-dose CT analysis
- Author
-
Sofia Ramiro, Désirée van der Heijde, Xenofon Baraliakos, Monique Reijnierse, Juergen Braun, Floris A van Gaalen, Mary Lucy Marques, Caroline Bastiaenen, Nuno Pereira da Silva, and Rosalinde Stal
- Subjects
Medicine - Abstract
Objective To investigate whether in radiographic axial spondyloarthritis (r-axSpA) inflammation is associated with lower trabecular bone density (TBD), and subsequently, if a lower TBD increases the likelihood of 2-year bone formation at the same vertebra.Methods Whole spine (C3–L5) data from patients included in the multicentre 2-year Sensitive Imaging in Ankylosing Spondylitis cohort was used. Two readers measured baseline TBD by Hounsfield units (HU) on low-dose CT (ldCT). Baseline MRI bone marrow oedema (BME) status scores and ldCT syndesmophyte formation and/or growth change-from-baseline scores were assessed by three and two readers, respectively. Average of readers’ continuous measurements or readers’ agreement in binary scores generated within the same vertebra (1—present in ≥1 quadrant/0—absent in all quadrants) were used. Multilevel generalised estimating equations models were used, the unit of analysis being the vertebra.Results In 50 patients with r-axSpA, TBD HU decreased from cranial to caudal vertebrae. Baseline MRI-BME was present in 300/985 (30%) and syndesmophytes in 588/910 (65%) vertebrae, both most prevalent at thoracolumbar region. Syndesmophyte formation or growth was observed in 18% of at-risk vertebrae (124/691). A significant confounder-adjusted association was found between inflammation and lower TBD (regression coefficient=−51; 95% CI−63 to −39). TBD was not associated with 2-year syndesmophyte formation or growth (adjusted OR 1.00; 95% CI 0.99 to 1.00).Conclusion In r-axSpA, while vertebral inflammation was associated with lower vertebral TBD, lower vertebral TBD itself did not increase the risk for new bone formation at the same vertebra. In preventing syndesmophyte progression, targeting local inflammation seems more important than targeting vertebral trabecular bone loss.
- Published
- 2023
- Full Text
- View/download PDF
14. Role of vertebral corner inflammation and fat deposition on MRI on syndesmophyte development detected on whole spine low-dose CT scan in radiographic axial spondyloarthritis
- Author
-
Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Xenofon Baraliakos, Monique Reijnierse, Alexandre Sepriano, Floris van Gaalen, Rosaline van den Berg, and Rosalinde Stal
- Subjects
Medicine - Abstract
Objectives To investigate the associations between MRI detected vertebral corner inflammation (VCI) and vertebral corner fat deposition (VCFD) on whole spine low-dose CT scan (ldCT) detected syndesmophyte formation and growth.Methods Patients from the Sensitive Imaging in Ankylosing Spondylitis cohort underwent MRI (baseline, 1 year and 2 years) and ldCT (baseline and 2 years). MR images were scored by three readers for VCI and VCFD, MRI patterns were defined by presence of VCI and/or VCFD over 2 years. LdCT images were scored by two central readers for presence and size of syndesmophytes and change was calculated for new or new/grown syndesmophytes. Multilevel generalised estimated equations were used to test the associations between VCI and VCFD and syndesmophyte development.Results Fifty radiographic patients with axial spondyloarthritis were included (mean age 49 years, 86% male, 78% HLA-B27+). Absence of both VCI and VCFD protected against syndesmophyte development (ORs 0.36–0.37). Presence of VCI and/or VCFD increased the risk of syndesmophyte development (ORs 1.73–2.60). Out of all corners with a new or new/grown syndesmophyte, 47% of corners according to reader 1 and 44% according to reader 2 had neither VCI nor VCFD preceding the bone formation.Conclusions VCI and VCFD were positively associated with syndesmophyte development. This has been shown for the first time for syndesmophytes detected on ldCT and also in the thoracic spine. However, almost half of all bone formation occurred in corners without VCI or VCFD, suggesting the presence of these lesions in yearly MRIs does not fully clarify the development of syndesmophytes.
- Published
- 2022
- Full Text
- View/download PDF
15. A systematic literature review informing the consensus statement on efficacy and safety of pharmacological treatment with interleukin-6 pathway inhibition with biological DMARDs in immune-mediated inflammatory diseases
- Author
-
Désirée van der Heijde, Maxime Dougados, Naveed Sattar, Tsutomu Takeuchi, Iain B McInnes, Daniel Aletaha, Tanja A Stamm, Christian Dejaco, Josef S Smolen, Gerd R Burmester, Kevin Winthrop, Michael Trauner, Angelo Ravelli, Andreas Kerschbaumer, Eva Chwala, Kastriot Kastrati, and Marieke J H Voshaar
- Subjects
Medicine - Abstract
Objectives Informing an international task force updating the consensus statement on efficacy and safety of biological disease-modifying antirheumatic drugs (bDMARDs) selectively targeting interleukin-6 (IL-6) pathway in the context of immune-mediated inflammatory diseases.Methods A systematic literature research of all publications on IL-6 axis inhibition with bDMARDs published between January 2012 and December 2020 was performed using MEDLINE, EMBASE and Cochrane CENTRAL databases. Efficacy and safety outcomes were assessed in clinical trials including their long-term extensions and observational studies. Meeting abstracts from ACR, EULAR conferences and results on clinicaltrials.gov were taken into consideration.Results 187 articles fulfilled the inclusion criteria. Evidence for positive effect of IL-6 inhibition was available in various inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, Takayasu arteritis, adult-onset Still’s disease, cytokine release syndrome due to chimeric antigen receptor T cell therapy and systemic sclerosis-associated interstitial lung disease. Newcomers like satralizumab and anti-IL-6 ligand antibody siltuximab have expanded therapeutic approaches for Castleman’s disease and neuromyelitis optica, respectively. IL-6 inhibition did not provide therapeutic benefits in psoriatic arthritis, ankylosing spondylitis and certain connective tissue diseases. In COVID-19, tocilizumab (TCZ) has proven to be therapeutic in advanced disease. Safety outcomes did not differ from other bDMARDs, except higher risks of diverticulitis and lower gastrointestinal perforations. Inconsistent results were observed in several studies investigating the risk for infections when comparing TCZ to TNF-inhibitors.Conclusion IL-6 inhibition is effective for treatment of several inflammatory diseases with a safety profile that is widely comparable to other bDMARDs.
- Published
- 2022
- Full Text
- View/download PDF
16. Upadacitinib in active ankylosing spondylitis: results of the 2-year, double-blind, placebo-controlled SELECT-AXIS 1 study and open-label extension
- Author
-
Désirée van der Heijde, Filip van den Bosch, Atul Deodhar, Joachim Sieper, Bernard Combe, Walter P Maksymowych, In-Ho Song, Tae-Hwan Kim, Mitsumasa Kishimoto, Yuanyuan Duan, Yunxia Sui, Andrew J Östör, and Peter K Wung
- Subjects
Medicine - Abstract
Introduction Long-term safety and efficacy of upadacitinib in patients with active ankylosing spondylitis (AS) has not been previously reported.Methods In SELECT-AXIS 1, patients receiving placebo were switched to upadacitinib 15 mg once daily at week 14 while patients initially randomised to upadacitinib continued their regimen through week 104. Efficacy was assessed using as-observed (AO) and non-responder imputation (NRI).Results Of 187 patients randomised, 144 patients (77%) completed week 104. Among patients receiving continuous upadacitinib, 85.9% (AO) and 65.6% (NRI) achieved Assessment of SpondyloArthritis international Society 40 response (ASAS40) at week 104. Similar magnitude of ASAS40 responses were observed among patients who switched from placebo to upadacitinib (88.7% and 63.8%, respectively). The mean change from baseline to week 104 in Spondyloarthritis Research Consortium of Canada MRI spine and sacroiliac joint inflammation scores were –7.3 and –5.3, respectively, in the continuous upadacitinib group and –7.9 and –4.9 in the placebo-to-upadacitinib switch group. The mean (95% CI) change from baseline to week 104 in the modified Stoke Ankylosing Spondylitis Spine Score was 0.7 (0.3, 1.1) in the total group. Adverse event rate was 242.7/100 patient-years. No serious infections, adjudicated major adverse cardiovascular events, lymphoma, non-melanoma skin cancer, or gastrointestinal perforations were observed.Conclusions Upadacitinib 15 mg once daily showed sustained and consistent efficacy over 2 years for ASAS40 and other clinically relevant endpoints. A low rate of radiographic progression was observed and no new safety findings were observed.
- Published
- 2022
- Full Text
- View/download PDF
17. Low-dose CT hounsfield units: a reliable methodology for assessing vertebral bone density in radiographic axial spondyloarthritis
- Author
-
Sofia Ramiro, Désirée van der Heijde, Xenofon Baraliakos, Monique Reijnierse, Juergen Braun, Floris A van Gaalen, Mary Lucy Marques, and Nuno Pereira da Silva
- Subjects
Medicine - Published
- 2022
- Full Text
- View/download PDF
18. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study
- Author
-
Robert Landewé, Désirée van der Heijde, Atul Deodhar, Martin Rudwaleit, Lianne S Gensler, Walter P Maksymowych, Bengt Hoepken, Lars Bauer, Thomas Kumke, Mindy Kim, and Simone Emanuele Auteri
- Subjects
Medicine - Published
- 2022
- Full Text
- View/download PDF
19. Geographical prevalence of family history in patients with axial spondyloarthritis and its association with HLA-B27 in the ASAS-PerSpA study
- Author
-
Désirée van der Heijde, Joachim Sieper, Clementina López-Medina, Anne Boel, Floris A van Gaalen, and Miranda van Lunteren
- Subjects
Medicine - Published
- 2022
- Full Text
- View/download PDF
20. Measuring quality of life of patients with axial spondyloarthritis for economic evaluation
- Author
-
Désirée van der Heijde, Pedro M Machado, Roberta Ramonda, Maura C Couto, Helena Santos, Floris A van Gaalen, Karen Minde Fagerli, Miguel Bernardes, Pedro D Carvalho, Sofia Exarchou, Allan Wailoo, Monica Hernandez Alava, Georgios Chrysanthou, Filipe Barcelos, Laura Gago, Maria Margarida Cunha, and Marleen van de Sande
- Subjects
Medicine - Published
- 2022
- Full Text
- View/download PDF
21. Identification of clinical phenotypes of peripheral involvement in patients with spondyloarthritis, including psoriatic arthritis: a cluster analysis in the worldwide ASAS-PerSpA study
- Author
-
Robert Landewé, Désirée van der Heijde, Maxime Dougados, Fernando M Pimentel-Santos, Anna Molto, Joachim Sieper, Clementina López-Medina, Marina Magrey, Sylvie Chevret, Ruben Burgos-Vargas, Floris A van Gaalen, Alessandro Biglia, Mitsumasa Kishimoto, Tuncay Duruöz, Bassel Elzorkany, Najia Hajjaj-Hassouni, José Maldonado-Cocco, Nelly Ziade, Meghna Gavali, Shue-Fen Luo, Kim Tae-Jong, Jieruo Gu, Pál Geher, Wilson Bautista-Molano, Walter Maksymowych, Laura Muntean, and Sebastián E Ibáñez-Vodnizza
- Subjects
Medicine - Published
- 2021
- Full Text
- View/download PDF
22. Clinical characteristics of non-radiographic versus radiographic axial spondyloarthritis in Asia and non-radiographic axial spondyloarthritis in other regions: results of the cross-sectional ASAS-COMOSPA study
- Author
-
Désirée van der Heijde, Yuko Kaneko, Clementina López-Medina, Atsuo Taniguchi, Masato Okada, Shigeto Kobayashi, Tetsuya Tomita, Kazuki Yoshida, Yoshinori Komagata, Keisuke Ono, Gautam A Deshpande, Shinya Kaname, Shigeyoshi Tsuji, Yoshinori Taniguchi, Naomi Ichikawa, Taku Kawasaki, Kazuo Matsui, Kurisu Tada, Naoho Takizawa, Naoto Tamura, Sho Fukui, Satoshi Kawaai, and Mitsuhro Morita
- Subjects
Medicine - Published
- 2021
- Full Text
- View/download PDF
23. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study
- Author
-
Robert Landewé, Désirée van der Heijde, Philip J Mease, Hasan Tahir, Shephard Mpofu, Luminita Pricop, Proton Rahman, Atul Singhal, Sandra Navarra, Aimee Readie, Elke Boettcher, and Eumorphia Maria Delicha
- Subjects
Medicine - Abstract
Objective Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA) in the FUTURE 5 study. Here, we report 2-year (end-of-study) results from this study.Methods Adults with active PsA were randomised 2:2:2:3 to receive subcutaneous secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load or placebo at baseline; weeks 1, 2, 3 and 4; and every 4 weeks thereafter. Secukinumab could be escalated from 150 mg to 300 mg starting at week 52, if active signs of disease were observed based on physician’s assessment. Assessments at week 104 (2 years) included clinical end points and radiographic damage (mean change in van der Heijde-modified total Sharp score (vdH-mTSS)). Safety analysis included all patients who received ≥1 dose of study medication.Results Of the 996 patients randomised, 783 patients (78.6%) completed 2 years of treatment. Improvement in clinical end points was sustained through 2 years. The vdH-mTSS (mean change (SD)) was 0.10 (1.74; 300 mg), 0.52 (2.66; 150 mg) and 0.41 (2.20; 150 mg no load) at 2 years. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ≤0.5) at 2 years was 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150 mg no load).Conclusion Secukinumab with and without loading regimen provided sustained clinical efficacy and low radiographic progression through 2 years in patients with PsA. No new safety findings were reported.Trial registration number NCT02404350.
- Published
- 2021
- Full Text
- View/download PDF
24. Pharmacological and non-pharmacological therapeutic strategies in difficult-to-treat rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of difficult-to-treat rheumatoid arthritis
- Author
-
Désirée van der Heijde, Paco M J Welsing, Jacob M van Laar, Nadia M T Roodenrijs, György Nagy, Melinda Kedves, and Attila Hamar
- Subjects
Medicine - Abstract
Objectives To summarise, by a systematic literature review (SLR), the evidence regarding pharmacological and non-pharmacological therapeutic strategies in difficult-to-treat rheumatoid arthritis (D2T RA), informing the EULAR recommendations for the management of D2T RA.Methods PubMed, Embase and Cochrane databases were searched up to December 2019. Relevant papers were selected and appraised.Results Two hundred seven (207) papers studied therapeutic strategies. Limited evidence was found on effective and safe disease-modifying antirheumatic drugs (DMARDs) in patients with comorbidities and other contraindications that limit DMARD options (patients with obesity, hepatitis B and C, risk of venous thromboembolisms, pregnancy and lactation). In patients who previously failed biological (b-)DMARDs, all currently used b/targeted synthetic (ts-)DMARDs were found to be more effective than placebo. In patients who previously failed a tumour necrosis factor inhibitor (TNFi), there was a tendency of non-TNFi bDMARDs to be more effective than TNFis. Generally, effectiveness decreased in patients who previously failed a higher number of bDMARDs. Additionally, exercise, psychological, educational and self-management interventions were found to improve non-inflammatory complaints (mainly functional disability, pain, fatigue), education to improve goal setting, and self-management programmes, educational and psychological interventions to improve self-management.The identified evidence had several limitations: (1) no studies were found in patients with D2T RA specifically, (2) heterogeneous outcome criteria were used and (3) most studies had a moderate or high risk of bias.Conclusions This SLR underscores the scarcity of high-quality evidence on the pharmacological and non-pharmacological treatment of patients with D2T RA. Effectiveness of b/tsDMARDs decreased in RA patients who had failed a higher number of bDMARDs and a subsequent b/tsDMARD of a previously not targeted mechanism of action was somewhat more effective. Additionally, a beneficial effect of non-pharmacological interventions was found for improvement of non-inflammatory complaints, goal setting and self-management.
- Published
- 2021
- Full Text
- View/download PDF
25. Value of MRI and ultrasound for prediction of therapeutic response and erosive progression in patients with early rheumatoid arthritis managed by an aggressive treat-to-target strategy
- Author
-
Désirée van der Heijde, Tore K Kvien, Gunnstein Bakland, Lena Bugge Nordberg, Siri Lillegraven, Anna-Birgitte Aga, Joseph Sexton, Espen A Haavardsholm, Erik Rødevand, Hilde Berner Hammer, Ulf Sundin, Nina Paulshus Sundlisater, Hallvard Fremstad, Tor Magne Madland, Åse Stavland Lexberg, Hilde Haukeland, Christian Høili, Hilde Stray, Anne Noraas Bendvold, and Inger W Hansen
- Subjects
Medicine - Abstract
Objectives To investigate if inflammation detected by MRI or ultrasound at rheumatoid arthritis (RA) onset is predictive of erosive progression or poor response to methotrexate monotherapy, and to investigate if subclinical inflammation in remission is predictive of future treatment escalation or erosive progression.Methods In a 2-year study, 218 patients with disease-modifying antirheumatic drug-naïve early RA were treated by a tight-control treat-to-target strategy corresponding to current recommendations. MRI and ultrasound were performed at regular intervals. Baseline imaging-based inflammation measures were analysed as predictors for early methotrexate failure and erosive progression using univariate and multivariate regression adjusted for clinical, laboratory and radiographic measures. In patients in remission after 1 year, imaging measures were analysed as predictors of treatment escalation and erosive progression during the second year. The added value of imaging in prediction models was assessed using receiver operating characteristic analyses.Results Baseline MRI inflammation was associated with MRI erosive progression and ultrasound with radiographic erosive progression. No imaging inflammation measure was associated with early methotrexate failure. Imaging inflammation was present in a majority of patients in clinical remission. Tenosynovitis was associated with treatment escalation, and synovitis and tenosynovitis with MRI/radiographic erosive progression during the second year. Imaging information did not improve prediction models for any of the outcomes.Conclusions Imaging-detected inflammation, both at diagnosis and in remission, is associated with elements of future disease development. However, the lack of a significant effect on prediction models indicates limited value of systematic MRI and ultrasound in management of early RA.
- Published
- 2021
- Full Text
- View/download PDF
26. Diagnostic issues in difficult-to-treat rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of difficult-to-treat rheumatoid arthritis
- Author
-
Désirée van der Heijde, Paco M J Welsing, Jacob M van Laar, Nadia M T Roodenrijs, György Nagy, Melinda Kedves, and Attila Hamar
- Subjects
Medicine - Abstract
Objectives To summarise the evidence on diagnostic issues in difficult-to-treat rheumatoid arthritis (D2T RA) informing the EULAR recommendations for the management of D2T RA.Methods A systematic literature review (SLR) was performed regarding the optimal confirmation of a diagnosis of rheumatoid arthritis (RA) and of mimicking diseases and the assessment of inflammatory disease activity. PubMed and Embase databases were searched up to December 2019. Relevant papers were selected and appraised.Results Eighty-two papers were selected for detailed assessment. The identified evidence had several limitations: (1) no studies were found including D2T RA patients specifically, and only the minority of studies included RA patients in whom there was explicit doubt about the diagnosis of RA or presence of inflammatory activity; (2) mostly only correlations were reported, not directly useful to evaluate the accuracy of detecting inflammatory activity in clinical practice; (3) heterogeneous, and often suboptimal, reference standards were used and (4) (thus) only very few studies had a low risk of bias.To ascertain a diagnosis of RA or relevant mimicking disease, no diagnostic test with sufficient validity and accuracy was identified. To ascertain inflammatory activity in patients with RA in general and in those with obesity and fibromyalgia, ultrasonography (US) was studied most extensively and was found to be the most promising diagnostic test.Conclusions This SLR highlights the scarcity of high-quality studies regarding diagnostic issues in D2T RA. No diagnostic tests with sufficient validity and accuracy were found to confirm nor exclude the diagnosis of RA nor its mimicking diseases in D2T RA patients. Despite the lack of high-quality direct evidence, US may have an additional value to assess the presence of inflammatory activity in D2T RA patients, including those with concomitant obesity or fibromyalgia.
- Published
- 2021
- Full Text
- View/download PDF
27. Prevalence and distribution of peripheral musculoskeletal manifestations in spondyloarthritis including psoriatic arthritis: results of the worldwide, cross-sectional ASAS-PerSpA study
- Author
-
Robert Landewé, Désirée van der Heijde, Maxime Dougados, Anna Molto, Joachim Sieper, Pedro M Machado, Clementina López-Medina, Uta Kiltz, Sebastián E Ibáñez Vodnizza, Sara Monti, Marina Magrey, Ruben Burgos-Vargas, Victoria Navarro-Compán, Floris A van Gaalen, Mitsumasa Kishimoto, Tuncay Duruöz, Bassel Elzorkany, Najia Hajjaj-Hassouni, José Maldonado-Cocco, Nelly Ziade, Meghna Gavali, Shue-Fen Luo, Kim Tae-Jong, F M Pimentel-Santos, Jieruo Gu, Ruxandra Schiotis, Pál Geher, Wilson Bautista-Molano, and Walter Maksymowych
- Subjects
Medicine - Abstract
Objectives To characterise peripheral musculoskeletal involvement in patients with spondyloarthritis (SpA) including psoriatic arthritis (PsA), across the world.Methods Cross-sectional study with 24 participating countries. Patients with a diagnosis of axial SpA (axSpA), peripheral SpA (pSpA) or PsA according to their rheumatologist were included. The investigators were asked which diagnosis out of a list of six (axSpA, PsA, pSpA, inflammatory bowel disease-associated SpA, reactive arthritis or juvenile SpA (Juv-SpA)) fitted the patient best. Peripheral manifestations (ie, peripheral joint disease, enthesitis, dactylitis and root joint disease), their localisation and treatments were evaluated.Results A total of 4465 patients were included (61% men, mean age 44.5 years) from four geographic areas: Latin America (n=538), Europe plus North America (n=1677), Asia (n=975) and the Middle East plus North Africa (n=1275). Of those, 78% had ever suffered from at least one peripheral musculoskeletal manifestation; 57% had peripheral joint disease, 44% had enthesitis and 15% had dactylitis. Latin American had far more often peripheral joint disease (80%) than patients from other areas. Patients with PsA had predominantly upper limb and small joint involvement (52%).Hip and shoulder involvement was found in 34% of patients. The prevalence of enthesitis ranged between 41% in patients with axSpA and 65% in patients with Juv-SpA. Dactylitis was most frequent among patients with PsA (37%).Conclusion These results suggest that all peripheral features can be found in all subtypes of SpA, and that differences are quantitative rather than qualitative. In a high proportion of patients, axial and peripheral manifestations coincided. These findings reconfirm SpA clinical subtypes are descendants of the same underlying disease, called SpA.
- Published
- 2021
- Full Text
- View/download PDF
28. Identifying the preferable rheumatoid arthritis subgroups for intervention with the anti-RANKL antibody denosumab to reduce progression of joint destruction
- Author
-
Désirée van der Heijde, Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Satoshi Soen, Toshiyuki Yoneda, Sakae Tanaka, Takaya Nitta, Naoki Okubo, Naoki Ishiguro, Takeshi Ohira, and Harry Genant
- Subjects
Medicine - Abstract
Objectives To clarify which rheumatoid arthritis (RA) patients benefit most from the anti-receptor activator of nuclear factor-κB ligand antibody denosumab to reduce the progression of joint destruction.Methods We pooled patient data from the 12-month, double-blind, placebo-controlled DRIVE (phase II) and DESIRABLE (phase III) studies. In DRIVE, concomitant treatment was limited to methotrexate, salazosulfapyridine and bucillamine. In DESIRABLE, patients could receive any disease-modifying antirheumatic drug. RA patients were randomised to denosumab 60 mg every 6 months (Q6M), every 3 months (Q3M) or placebo. Efficacy was assessed by van der Heijde-modified total Sharp score (mTSS), bone erosion score (ES) and joint space narrowing score (JSNS). Change in mTSS was assessed in subgroups stratified by risk factors for radiographic damage if the interaction factor was significant.Results The pooled analysis included 909 patients. Denosumab reduced worsening of mTSS (mean (SD)) at 12 months in the Q6M (0.88 (3.30), p=0.0024) and Q3M (0.66 (2.16), p=0.0002) groups versus placebo (1.50 (3.73)). This reduction in mTSS progression was due to the change in ES (Q6M, 0.44 (1.89), p=0.0006; Q3M, 0.20 (0.86), p
- Published
- 2020
- Full Text
- View/download PDF
29. Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry
- Author
-
Désirée van der Heijde, Ana Maria Gherghe, and Yune-Jung Park
- Subjects
Medicine - Abstract
Objectives To summarise radiographic data in randomised controlled trials (RCTs) as part of the radiographic inhibition claim of disease-modifying antirheumatic drugs (DMARDs) approved for patients with rheumatoid arthritis (RA).Methods A systemic literature review was performed using the Medline database from 1994 to February 2020. The results were grouped based on the scoring methods (Sharp, Genant modification, van der Heijde modification) and RA patient populations.Results One hundred sixty-eight publications were selected. After detailed assessment, 52 RCTs (7 methotrexate (MTX)-naive, 23 MTX inadequate response (IR), 9 DMARDs IR and 3 tumour necrosis factor-alpha inhibitors (TNFi) IR studies) were finally included. Information on patient population, scoring method used, reader reliability, statistical analyses and detailed radiographic data on baseline and change scores over multiple follow-up periods are presented.Conclusion The data gathered in this review serve as a repository for the design of future trials with radiographic damage as an outcome.
- Published
- 2020
- Full Text
- View/download PDF
30. Development of classification criteria for hand osteoarthritis: comparative analyses of persons with and without hand osteoarthritis
- Author
-
Francis Berenbaum, Désirée van der Heijde, Margreet Kloppenburg, Abhishek Abhishek, Tanja A Stamm, Ida K Haugen, Ruth Wittoek, Féline PB Kroon, Elsie Greibrokk, Helgi Jonsson, Emmanuel Maheu, Roberta Ramonda, Wilma Smeets, Valentin Ritschl, David T Felson, Sita Bierma-Zeinstra, Tove Borgen, Gabriel Herrero Beaumont, and Mariko Ishimori
- Subjects
Medicine - Abstract
Objectives Further knowledge about typical hand osteoarthritis (OA) characteristics is needed for the development of new classification criteria for hand OA.Methods In a cross-sectional multi-centre international study, a convenience sample of patients from primary and secondary/tertiary care with a physician-based hand OA diagnosis (n = 128) were compared with controls with hand complaints due to inflammatory or non-inflammatory conditions (n = 70). We examined whether self-reported, clinical, radiographic and laboratory findings were associated with hand OA using logistic regression analyses. Discrimination between groups was assessed by calculating the area under receiver operating curves (AUC).Results Strong associations with hand OA were observed for radiographic osteophytes (OR = 1.62, 95% CI 1.40 to 1.88) and joint space narrowing (JSN) (OR = 1.57, 95% CI 1.36 to 1.82) in the distal interphalangeal (DIP) joints with excellent discrimination (AUC = 0.82 for both). For osteophytes and JSN, we found acceptable discrimination between groups in the proximal interphalangeal joints (AUC = 0.77 and 0.78, respectively), but poorer discrimination in the first carpometacarpal joints (AUC = 0.67 and 0.63, respectively). Painful DIP joints were associated with hand OA, but were less able to discriminate between groups (AUC = 0.67). Age and family history of OA were positively associated with hand OA, whereas negative associations were found for pain, stiffness and soft tissue swelling in metacarpophalangeal joints, pain and marginal erosions in wrists, longer morning stiffness, inflammatory biomarkers and autoantibodies.Conclusions Differences in symptoms, clinical findings, radiographic changes and laboratory tests were found in patients with hand OA versus controls. Radiographic OA features, especially in DIP joints, were best suited to discriminate between groups.
- Published
- 2020
- Full Text
- View/download PDF
31. 5-year follow-up of spinal and sacroiliac MRI abnormalities in early axial spondyloarthritis: data from the DESIR cohort
- Author
-
Sofia Ramiro, Désirée van der Heijde, Maxime Dougados, Anna Molto, Pascal Claudepierre, Alexandre Sepriano, Floris A van Gaalen, Queeny Madari, and Daniel Wendling
- Subjects
Medicine - Abstract
Objective To study changes on MRI of the spine and sacroiliac joint (SIJ) in early axial spondyloarthritis (axSpA) over time.Methods In the Devenir des Spondyloarthropathies Indifférenciées Récentes cohort, MRI-spine and MRI-SIJ at baseline and 2 and 5 years were scored by central readers for bone marrow oedema (BME), fatty lesions, erosions, sclerosis, ankylosis and spinal bone spurs. The average mean number of lesions was reported or the agreement of ≥2 out of 3 readers for binary outcomes. Net progression was calculated by subtracting the patients that ‘improved’ from those that ‘worsened’ divided by the total number of patients.Results Over 5 years, in 155 patients with axSpA (mean age 33.5 (SD 8.9) years, symptom duration 1.4 (0.8) years, 63% human leucocyte antigen+, 14% modified New York+), BME on MRI-SIJ decreased by a mean Spondyloarthritis Research Consortium of Canada score of 1.4 (SD 6.5) (p=0.009). The largest BME decrease was observed in patients using biological disease-modifying antirheumatic drugs at 5 years. Spinal BME increased by 0.3 (4.6) (p=0.41). Fatty lesions and/or erosions on MRI-SIJ increased by a mean of 1.0 (SD 2.6) (p
- Published
- 2020
- Full Text
- View/download PDF
32. Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis
- Author
-
Désirée van der Heijde, Yoshiya Tanaka, Paul Emery, Li Xie, Michael Schiff, Gabriella Meszaros, Taeko Ishii, Marta Casillas, and Robert A Ortmann
- Subjects
Medicine - Abstract
Objectives To evaluate radiographic progression of structural joint damage over 2 years in patients with rheumatoid arthritis from baricitinib clinical trials who were disease-modifying antirheumatic drug (DMARD)–naïve or had an inadequate response to conventional synthetic DMARDs (csDMARD-IR).Methods Patients had completed one of three phase III studies and entered a long-term extension (LTE) study, continuing on the same baricitinib dose as at originating study completion. At 52 weeks, DMARD-naïve patients receiving methotrexate (MTX) or combination therapy (baricitinib 4 mg+MTX) were switched to baricitinib 4 mg monotherapy (±MTX per investigator opinion); MTX-IR patients receiving adalimumab were switched to baricitinib 4 mg on background MTX. At 24 weeks, csDMARD-IR patients receiving placebo were switched to baricitinib 4 mg on background csDMARD. Radiographs at baseline, year 1 and year 2 were scored using the van der Heijde modified Total Sharp Score. Linear extrapolation was used for missing data.Results Of 2573 randomised patients, 2125 (82.6%) entered the LTE, of whom 1893 (89.1%) entered this analysis. At year 2, progression was significantly lower with initial baricitinib (monotherapy or combination therapy) versus initial MTX in DMARD-naïve patients (proportion with non-progression defined by ≤smallest detectable change (SDC): 87.3% baricitinib 4 mg+MTX; 70.6% MTX; p≤ 0.001). In MTX-IR patients, progression with initial baricitinib was significantly lower than with initial placebo and similar to initial adalimumab (≤SDC: 82.7% baricitinib 4 mg; 83.5% adalimumab; 70.6% placebo; p≤0.001). In csDMARD-IR patients, significant benefit was seen with baricitinib 4 mg (≤SDC: 87.2% vs 73.2% placebo; p≤0.01).Conclusions Treatment with once-daily baricitinib resulted in low rates of radiographic progression for up to 2 years.
- Published
- 2019
- Full Text
- View/download PDF
33. Development of one general and six country-specific algorithms to assess societal health utilities based on ASAS HI
- Author
-
Désirée van der Heijde, Annelies Boonen, Juergen Braun, Uta Kiltz, Ivette Essers, Mickael Hiligsmann, and Nick Bansback
- Subjects
Medicine - Abstract
Objective Health utilities represent preference values that persons attach to health states. This study aims to develop one general and six country-specific algorithms to calculate societal preference values for health of patients with spondyloarthritis (SpA), as assessed by the disease-specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI).Methods A survey was performed in random population samples from six European countries. In a best-worst choice experiment, subjects were asked to indicate repeatedly which of 4 random aspects of the 17-item ASAS HI was were most and least important. Bayesian analysis provided the relative importance of each of the 17 items. To rescale the relative importance scores on the absolute utility scale between 0 and 1, participants additionally completed two lead time trade-off experiments, one for ‘severe SpA’ and one for ‘best health’ without SpA. Six country-specific algorithms and one general algorithm were derived. The general algorithm was tested in 199 patients with axial SpA (axSpA).Results 3039 subjects, mean age 47 years (SD 15) and 52% female completed the experiments. The population’s health utility value for SpA varied between − 0.24 for ‘worst’ SpA (country range −0.35 to 0.03), and 0.88 for ‘best’ health (country range 0.81 to 0.90). Among 199 patients with axSpA, the mean utility was 0.36 (SD 0.30, range −0.24 to 0.88) and discriminated well between patients having high (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4) or low (BASDAI < 4) disease activity (0.18 (SD 0.24) vs 0.51(SD 0.27), p
- Published
- 2019
- Full Text
- View/download PDF
34. Percentage of progressors in imaging: can we ignore regressors?
- Author
-
Sofia Ramiro, Robert Landewé, Désirée van der Heijde, Maxime Dougados, and Alexandre Sepriano
- Subjects
Medicine - Abstract
Stopping or preventing structural progression is a goal common to all inflammatory rheumatic diseases. Imaging may capture structural progression across diseases, but is susceptible to measurement error. Progression can be analysed as a continuous change score over time (eg, mean change of the van der Heijde-modified Sharp score) or as a binary change score (eg, percentage of progressors according to the modified New York criteria). Here, we argue that the former takes measurement error into account while the latter ignores it, which may lead to spurious conclusions. We will argue that assumptions underlying commonly used binary definitions of progression are false and we propose a method that incorporates (inevitable) measurement error.
- Published
- 2019
- Full Text
- View/download PDF
35. Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry
- Author
-
Yune-Jung Park, Désirée van der Heijde, and Ana Maria Gherghe
- Subjects
medicine.medical_specialty ,Radiography ,Ankylosing Spondylitis ,Immunology ,lcsh:Medicine ,Arthritis ,Rheumatoid Arthritis ,Systemic Sclerosis ,Autoimmune Diseases ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Synovitis ,Internal medicine ,Spondyloarthritis ,medicine ,Immunology and Allergy ,Humans ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,030203 arthritis & rheumatology ,Inflammation ,Ankylosing spondylitis ,Clinical Trials as Topic ,Duration of Therapy ,business.industry ,lcsh:R ,Disease Management ,medicine.disease ,Clinical trial ,Treatment Outcome ,Outcomes research ,Rheumatoid arthritis ,Antirheumatic Agents ,Disease Progression ,Methotrexate ,business ,Biomarkers ,medicine.drug - Abstract
ObjectivesTo summarise radiographic data in randomised controlled trials (RCTs) as part of the radiographic inhibition claim of disease-modifying antirheumatic drugs (DMARDs) approved for patients with rheumatoid arthritis (RA).MethodsA systemic literature review was performed using the Medline database from 1994 to February 2020. The results were grouped based on the scoring methods (Sharp, Genant modification, van der Heijde modification) and RA patient populations.ResultsOne hundred sixty-eight publications were selected. After detailed assessment, 52 RCTs (7 methotrexate (MTX)-naive, 23 MTX inadequate response (IR), 9 DMARDs IR and 3 tumour necrosis factor-alpha inhibitors (TNFi) IR studies) were finally included. Information on patient population, scoring method used, reader reliability, statistical analyses and detailed radiographic data on baseline and change scores over multiple follow-up periods are presented.ConclusionThe data gathered in this review serve as a repository for the design of future trials with radiographic damage as an outcome.
- Published
- 2020
36. 5-year follow-up of spinal and sacroiliac MRI abnormalities in early axial spondyloarthritis: data from the DESIR cohort
- Author
-
Alexandre Sepriano, Sofia Ramiro, Désirée van der Heijde, Anna Molto, Maxime Dougados, Pascal Claudepierre, Daniel Wendling, Floris A. van Gaalen, and Queeny Madari
- Subjects
Adult ,Male ,medicine.medical_specialty ,5 year follow up ,Immunology ,lcsh:Medicine ,Cohort Studies ,Rheumatology ,HLA Antigens ,Internal medicine ,Spondylarthritis ,Spondyloarthritis ,ankylosing spondylitis ,medicine ,Ankylosis ,Immunology and Allergy ,Edema ,Humans ,Longitudinal Studies ,Prospective Studies ,Axial spondyloarthritis ,Bone Marrow Diseases ,Sacroiliac joint ,Ankylosing spondylitis ,business.industry ,lcsh:R ,Sacroiliac Joint ,medicine.disease ,Magnetic Resonance Imaging ,Spine ,medicine.anatomical_structure ,Adipose Tissue ,Antirheumatic Agents ,Cohort ,Bone spurs ,Disease Progression ,Female ,Radiology ,medicine.symptom ,business ,Follow-Up Studies ,MRI - Abstract
ObjectiveTo study changes on MRI of the spine and sacroiliac joint (SIJ) in early axial spondyloarthritis (axSpA) over time.MethodsIn the Devenir des Spondyloarthropathies Indifférenciées Récentes cohort, MRI-spine and MRI-SIJ at baseline and 2 and 5 years were scored by central readers for bone marrow oedema (BME), fatty lesions, erosions, sclerosis, ankylosis and spinal bone spurs. The average mean number of lesions was reported or the agreement of ≥2 out of 3 readers for binary outcomes. Net progression was calculated by subtracting the patients that ‘improved’ from those that ‘worsened’ divided by the total number of patients.ResultsOver 5 years, in 155 patients with axSpA (mean age 33.5 (SD 8.9) years, symptom duration 1.4 (0.8) years, 63% human leucocyte antigen+, 14% modified New York+), BME on MRI-SIJ decreased by a mean Spondyloarthritis Research Consortium of Canada score of 1.4 (SD 6.5) (p=0.009). The largest BME decrease was observed in patients using biological disease-modifying antirheumatic drugs at 5 years. Spinal BME increased by 0.3 (4.6) (p=0.41). Fatty lesions and/or erosions on MRI-SIJ increased by a mean of 1.0 (SD 2.6) (pConclusionOver 5 years, BME on MRI-SIJ decreased and spinal BME remained similar, but numerically, little progression of structural lesions on MRI of the SIJ and spine was seen.
- Published
- 2020
37. Low rates of radiographic progression of structural joint damage over 2 years of baricitinib treatment in patients with rheumatoid arthritis
- Author
-
R Ortmann, Paul Emery, T. Ishii, Marta Casillas, Gabriella Meszaros, Désirée van der Heijde, Michael Schiff, Li Xie, and Yoshiya Tanaka
- Subjects
musculoskeletal diseases ,rheumatoid arthritis ,medicine.medical_specialty ,dmards (synthetic) ,Combination therapy ,Radiography ,Immunology ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Adalimumab ,Immunology and Allergy ,In patient ,autoimmune diseases ,030212 general & internal medicine ,skin and connective tissue diseases ,030203 arthritis & rheumatology ,business.industry ,Correction ,medicine.disease ,Clinical trial ,Rheumatoid arthritis ,Methotrexate ,business ,medicine.drug - Abstract
ObjectivesTo evaluate radiographic progression of structural joint damage over 2 years in patients with rheumatoid arthritis from baricitinib clinical trials who were disease-modifying antirheumatic drug (DMARD)–naïve or had an inadequate response to conventional synthetic DMARDs (csDMARD-IR).MethodsPatients had completed one of three phase III studies and entered a long-term extension (LTE) study, continuing on the same baricitinib dose as at originating study completion. At 52 weeks, DMARD-naïve patients receiving methotrexate (MTX) or combination therapy (baricitinib 4 mg+MTX) were switched to baricitinib 4 mg monotherapy (±MTX per investigator opinion); MTX-IR patients receiving adalimumab were switched to baricitinib 4 mg on background MTX. At 24 weeks, csDMARD-IR patients receiving placebo were switched to baricitinib 4 mg on background csDMARD. Radiographs at baseline, year 1 and year 2 were scored using the van der Heijde modified Total Sharp Score. Linear extrapolation was used for missing data.ResultsOf 2573 randomised patients, 2125 (82.6%) entered the LTE, of whom 1893 (89.1%) entered this analysis. At year 2, progression was significantly lower with initial baricitinib (monotherapy or combination therapy) versus initial MTX in DMARD-naïve patients (proportion with non-progression defined by ≤smallest detectable change (SDC): 87.3% baricitinib 4 mg+MTX; 70.6% MTX; p≤ 0.001). In MTX-IR patients, progression with initial baricitinib was significantly lower than with initial placebo and similar to initial adalimumab (≤SDC: 82.7% baricitinib 4 mg; 83.5% adalimumab; 70.6% placebo; p≤0.001). In csDMARD-IR patients, significant benefit was seen with baricitinib 4 mg (≤SDC: 87.2% vs 73.2% placebo; p≤0.01).ConclusionsTreatment with once-daily baricitinib resulted in low rates of radiographic progression for up to 2 years.
- Published
- 2019
38. Comparing the disease course of patients with seronegative and seropositive rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria in a treat-to-target setting: 2-year data from the ARCTIC trial
- Author
-
Tore K Kvien, Désirée van der Heijde, Joseph Sexton, Inge C. Olsen, Hilde Berner Hammer, Anna-Birgitte Aga, Elisabeth Lie, L.B. Nordberg, Espen A Haavardsholm, Siri Lillegraven, and Till Uhlig
- Subjects
0301 basic medicine ,musculoskeletal diseases ,medicine.medical_specialty ,Immunology ,early rheumatoid arthritis ,Rheumatoid Arthritis ,Disease ,Disease course ,rheumatoid factor ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,Epidemiology ,medicine ,Immunology and Allergy ,Rheumatoid factor ,030203 arthritis & rheumatology ,business.industry ,medicine.disease ,The arctic ,anti-CCP ,030104 developmental biology ,Rheumatoid arthritis ,epidemiology ,business ,Rheumatism - Abstract
ObjectivesRecent studies suggest that implementation of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis (RA) leads to higher inflammatory activity in seronegative compared with seropositive patients at time of diagnosis. Our aim was to compare the disease course in seronegative and seropositive patients classified according to the 2010 criteria.MethodsDMARD-naïve patients with RA fulfilling the 2010 criteria were included in the treat-to-target ARCTIC trial and followed for 24 months. We stratified patients as seropositive (rheumatoid factor (RF)+, anticitrullinated protein antibodies (ACPA)+ or both) or seronegative (RF– and ACPA–) and compared disease activity, radiographic progression, treatment response and remission rates across groups.Results230 patients were included with mean (SD) age 51.4 (13.7) years, and 61% were female. 34 patients (15%) were seronegative. At 24 months, disease activity measures, radiographic progression and remission rates were similar between groups, despite more inflammatory activity in seronegative patients at baseline. Treatment response was slower in seronegative compared with seropositive patients. The groups received similar treatment.ConclusionOur findings suggest that among patients with RA classified according to the 2010 ACR/EULAR criteria, seronegative patients respond well to modern treatment strategies. However, treatment response was somewhat slower in seronegative patients and radiographic progression was similar in seronegative and seropositive patients. Our results indicate that seronegative RA is not a mild form of the disease and requires intensive treat-to-target therapy similar to treatment of seropositive RA.
- Published
- 2018
39. Employment and the role of personal factors among patients with ankylosing spondylitis: a Dutch cross-sectional case-control study
- Author
-
Simon van Genderen, Mart A F J van de Laar, Désirée van der Heijde, Anneke Spoorenberg, Jolanda J. Luime, Laura Vanhoof, Floris A. van Gaalen, Liesbeth Heuft, Annelies Boonen, Casper Webers, Psychology, Health & Technology, Interne Geneeskunde, Promovendi PHPC, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, MUMC+: MA Med Staf Artsass Interne Geneeskunde (9), MUMC+: MA Reumatologie (9), and Rheumatology
- Subjects
0301 basic medicine ,medicine.medical_specialty ,IMPACT ,Immunology ,Population ,Psychological intervention ,Disease ,Computer-assisted web interviewing ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Epidemiology ,Spondyloarthritis ,ankylosing spondylitis ,medicine ,Immunology and Allergy ,In patient ,WORK-PARTICIPATION ,education ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,education.field_of_study ,business.industry ,Case-control study ,medicine.disease ,030104 developmental biology ,PERSPECTIVES ,employment ,epidemiology ,business ,Demography - Abstract
Objectives To update the knowledge on employment and the role of mastery, a personal factor reflecting the level of control over life and disease, among Dutch patients with ankylosing spondylitis (AS) compared to general population subjects. Methods Data of persons ≤65 years participating in a Dutch cross-sectional multicentre study on social participation in AS were used. Being employed was the main outcome. Standardised employment ratios (SERs) were calculated using indirect standardisation after adjusting for age, gender and education and repeated after stratification by symptom duration tertiles. Modified Poisson regressions were performed to understand the role of mastery (Pearlin's scale) independent of sociodemographic and health-related factors. Results 214 patients and 470 controls (127 (59.3%) and 323 (68.7%) males; mean age 48.3 (SD 10.4) and 39.3 (SD 12.7) years, respectively) completed an online questionnaire. SER (95%CI) in patients was 0.83 (0.69-0.98); 0.84 (0.67-1.04) in males; 0.83 (0.59-1.07) in females. Adjusted absolute employment of patients compared to controls was 69% versus 84%; 73% versus 86% for males; 62% versus 78% for females. In multivariable analyses stratified for patients and controls, mastery was associated with being employed in patients, but only in those with low education. In controls, not mastery but higher education was associated with being employed. Conclusion Our study reveals that patients suffering from AS compared to population controls are less likely to be employed. Mastery is an important personal factor associated with employment in patients but not in controls. Interventions aimed at improving employment of patients with AS should likely account for mastery.
- Published
- 2018
40. Effects of baricitinib on radiographic progression of structural joint damage at 1 year in patients with rheumatoid arthritis and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs
- Author
-
Ying-Chou Chen, Li Xie, Edit Drescher, Terence Rooney, Paul Emery, Rena Klar, Désirée van der Heijde, Sarah Witt, Maxime Dougados, Inmaculada de la Torre, Maria Greenwald, Stephanie de Bono, and Douglas E Schlichting
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Baricitinib ,Radiography ,Immunology ,Rheumatoid Arthritis ,Disease ,csDMARD ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Immunology and Allergy ,baricitinib ,In patient ,030203 arthritis & rheumatology ,RA-BUILD ,business.industry ,medicine.disease ,Discontinuation ,030104 developmental biology ,radiographic progression ,Rheumatoid arthritis ,Joint damage ,business - Abstract
Background: Baricitinib was efficacious in a 24-week phase III study in patients with rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti rheumatic drugs (DMARDs) (csDMARDs) (RA-BUILD).\ud \ud \ud \ud Objectives: To evaluate radiographic progression of structural joint damage in RA-BUILD patients over 48 weeks of baricitinib treatment in the long-term extension study, RA-BEYOND.\ud \ud \ud \ud Methods: In RA-BUILD, patients were randomised to placebo, baricitinib 2 mg or 4 mg once daily, with rescue possible from week 16. Patients completing RA-BUILD and entering RA-BEYOND continued to receive the baricitinib dose received at the end of RA-BUILD. Patients receiving placebo were switched to baricitinib 4 mg in RA-BEYOND. Joint damage was measured using the van der Heijde modified total Sharp score. To account for missing scores and scores obtained after rescue, switch or discontinuation of study drug, data were analysed using (1) linear extrapolation (LE) and (2) observed/last observation carried forward (LOCF). The observed/LOCF method used all available observed data, including after rescue or switch, with patients analysed according to original treatment assignment.\ud \ud \ud \ud Results: Using LE, radiographic progression at 24 and 48 weeks was statistically significantly lower for both baricitinib 2 or 4 mg compared with placebo. Only baricitinib 4 mg demonstrated statistically significant inhibition of progressive radiographic joint damage compared with patients initially randomised to placebo using observed/LOCF at week 48.\ud \ud \ud \ud Conclusions: Once daily oral baricitinib inhibited radiographic progression of structural joint damage in patients with an inadequate response or intolerance to csDMARDs over 48 weeks. The most robust benefit was seen for the 4 mg dose.
- Published
- 2018
41. Prevalence of degenerative changes and overlap with spondyloarthritis-associated lesions in the spine of patients from the DESIR cohort
- Author
-
Freek de Bruin, Désirée van der Heijde, Marco O Treyvaud, Antoine Feydy, Johan L. Bloem, Monique Reijnierse, Manouk de Hooge, J.B. Pialat, Laure Gossec, and Maxime Dougados
- Subjects
medicine.medical_specialty ,Radiography ,Immunology ,03 medical and health sciences ,0302 clinical medicine ,Lumbar ,Rheumatology ,Internal medicine ,Spondyloarthritis ,ankylosing spondylitis ,Back pain ,Immunology and Allergy ,Medicine ,magnetic resonance imaging ,low back pain ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,medicine.diagnostic_test ,business.industry ,Magnetic resonance imaging ,Modic changes ,medicine.disease ,Low back pain ,Cohort ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Objectives To describe the prevalence of degenerative changes on MRI and conventional radiographs of the spine in a young population with suspicion of axial spondyloarthritis (axSpA) and assess whether it is possible to discriminate between degenerative changes and lesions associated with axSpA. Methods Whole spine MRI and cervical and lumbar radiographs of patients ≥18 years with chronic back pain (≥3 months, ≤3 years, onset
- Published
- 2018
42. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study
- Author
-
Désirée, van der Heijde, Jürgen, Braun, Martin, Rudwaleit, Oana, Purcaru, and Arthur F, Kavanaugh
- Subjects
treatment ,Spondyloarthritis ,ankylosing spondylitis ,autoimmune diseases ,anti-TNF ,TNF-alpha - Abstract
Objectives To evaluate the effect of certolizumab pegol (CZP) on work and household productivity, and on participation in family, social and leisure activities in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA. Methods RAPID-axSpA (NCT01087762) was a phase III, double-blind, placebo-controlled trial to week (Wk) 24, dose-blind to Wk48 and open-label to Wk204. A total of 325 patients were randomised 1:1:1 to placebo, CZP 200 mg Q2W or CZP 400 mg Q4W. The validated arthritis-specific Work Productivity Survey assessed the impact of axSpA on work and household productivity and participation in social activities during the preceding month. Data are shown to Wk96, with responses compared between treatment arms (placebo vs CZP 200 mg and 400 mg dose groups combined) and subpopulations using a non-parametric bootstrap-t method. Results At baseline, 63.2% of placebo and 72.0% of CZP patients were employed. By Wk24, CZP patients reported on average 1.0 fewer days of absenteeism and 2.6 fewer days of presenteeism per month, compared with 0.4 and 0.9 fewer days for placebo. At home, by Wk24, CZP patients reported on average 3.0 household work days gained per month versus 1.3 for placebo. CZP patients reported fewer days with reduced household productivity or days lost for social participation. Similar improvements were observed in AS and nr-axSpA subpopulations and improvements with CZP were maintained to Wk96. Conclusions Compared with placebo, treatment with CZP significantly improved work and household productivity and resulted in greater social participation for patients with axSpA, which could lead to considerable indirect cost gains. Trial registration number NCT01087762.
- Published
- 2018
43. Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis
- Author
-
C. Stach, Pedro Machado, Désirée van der Heijde, Walter P. Maksymowych, Robert Landewé, Kay-Geert A. Hermann, T. Nurminen, O. Davies, Bengt Hoepken, Jürgen Braun, Xenofon Baraliakos, AII - Inflammatory diseases, Clinical Immunology and Rheumatology, and AII - Amsterdam institute for Infection and Immunity
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Radiography ,Concordance ,Ankylosing Spondylitis ,Immunology ,Inflammation ,Placebo ,Imaging ,Anti-TNF ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,medicine ,Immunology and Allergy ,Certolizumab pegol ,Axial spondyloarthritis ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,medicine.diagnostic_test ,business.industry ,Magnetic resonance imaging ,medicine.disease ,Magnetic Resonance Imaging ,Surgery ,Treatment ,030104 developmental biology ,Radiology ,medicine.symptom ,business ,medicine.drug - Abstract
Objective To report MRI outcomes and explore the relationship between clinical remission and MRI inflammation in patients with axial spondyloarthritis (axSpA) from the RAPID-axSpA trial, including radiographic (r-)axSpA and non-radiographic (nr-)axSpA. Methods RAPID-axSpA (NCT01087762) was double-blind and placebo-controlled to week 24, dose-blind to week 48 and open-label to week 204. Patients were randomised to certolizumab pegol (CZP) or placebo. Placebo patients entering dose-blind were rerandomised to CZP. MRIs performed at baseline, weeks 12, 48 and 96 were scored by 2 reviewers independently: Spondyloarthritis Research Consortium of Canada (SPARCC) for sacroiliac (SI) joints; Berlin modification of the Ankylosing Spondylitis spine MRI scoring system for disease activity (Berlin) for spine. Inflammation thresholds: SPARCC≥2; Berlin>2. Remission thresholds: SPARCC
- Published
- 2017
- Full Text
- View/download PDF
44. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable
- Author
-
Roy Fleischmann, Annette Szumski, Eustratios Bananis, Philip Gardiner, Désirée van der Heijde, and Lisa Marshall
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,Immunology ,Rheumatoid Arthritis ,Gastroenterology ,Das28 esr ,Etanercept ,Disease activity ,Anti-TNF ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,immune system diseases ,Internal medicine ,medicine ,Immunology and Allergy ,DAS28 ,030212 general & internal medicine ,skin and connective tissue diseases ,030203 arthritis & rheumatology ,medicine.diagnostic_test ,biology ,business.industry ,C-reactive protein ,Baseline data ,medicine.disease ,Rheumatoid arthritis ,Erythrocyte sedimentation rate ,biology.protein ,Methotrexate ,business ,medicine.drug - Abstract
Background In most patients with rheumatoid arthritis (RA), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) is lower than DAS28 erythrocyte sedimentation rate (DAS28-ESR), suggesting that use of the DAS28-ESR cut-off to assess high disease activity (HDA) with DAS28-CRP may underestimate the number of patients with HDA. We determined the DAS28-CRP value corresponding to the validated DAS28-ESR cut-off for HDA. Methods Baseline data were pooled from 2 clinical studies evaluating etanercept (ETN) plus methotrexate (MTX) or MTX in early RA; DAS28-CRP and DAS28-ESR were obtained, allowing the determination of the DAS28-CRP HDA value best corresponding to the DAS28-ESR cut-off of >5.1. Results At baseline, as expected, fewer patients had HDA by DAS28-CRP than DAS28-ESR; DAS28-CRP>5.1 and DAS28-ESR>5.1 had only modest agreement (κ coefficients 0.45–0.54). Mean DAS28-CRP and DAS28-ESR were 5.7 and 6.2, respectively, in the ETN+MTX group (n=571), and 6.0 and 6.5 in the MTX group (n=262). A DAS28-CRP cut-off of 4.6 corresponded to a DAS28-ESR cut-off of 5.1. Conclusions We have shown that a DAS28-CRP of 4.6 corresponds to 5.1 for DAS28-ESR. Since this is substantially lower than the DAS28-ESR cut-off of 5.1, using 5.1 as the cut-off for DAS28-CRP underestimates disease activity in RA. Trial registration number NCT00195494; NCT00913458.
- Published
- 2017
45. When rheumatologists report that they agree with a guideline, does this mean that they practise the guideline in clinical practice? Results of the International Recommendation Implementation Study (IRIS)
- Author
-
Gianfranco Ferraccioli, E. Gvozdenovic, Cornelia F Allaart, Josef S Smolen, Désirée van der Heijde, Tom W J Huizinga, Robert Landewé, AII - Amsterdam institute for Infection and Immunity, and Clinical Immunology and Rheumatology
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,Settore MED/16 - REUMATOLOGIA ,Immunology ,Treatment outcome ,Alternative medicine ,Rheumatoid Arthritis ,DMARDs (biologic) ,Disease activity ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,DMARDs (synthetic) ,Disease Activity ,Treatment ,Immunology and Allergy ,medicine ,030212 general & internal medicine ,skin and connective tissue diseases ,030203 arthritis & rheumatology ,business.industry ,Guideline ,medicine.disease ,Clinical Practice ,Physical therapy ,Treatment strategy ,business ,Rheumatism - Abstract
Introduction The European League Against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA) and the treat-to-target (T2T) principles have been developed in order to improve the treatment outcome of patients with RA, and have received broad attention. It is not clear, though, whether these recommendations are indeed followed up in clinical practice. Objective To investigate if rheumatologists that report to agree with existing guidelines indeed follow them up in clinical practice. Methods The International Recommendation Implementation Study (IRIS) included 132 participating rheumatologists from 14 countries. Participating rheumatologists received a questionnaire measuring their awareness/commitment with the EULAR/T2T recommendations and followed a dedicated educational programme. Subsequently, they were asked to enrol 5–10 patients with new-onset RA in the online IRIS database and monitor disease activity and treatment for a period of 1–2 years. Four recommendations (3 from the EULAR recommendations and one from the T2T recommendations) were selected on the basis of testability, and analysed with regard to compliance by participating rheumatologists. Results In total, 72 of the 132 participating rheumatologists contributed 378 patients to the database. Of these participants, 70 (98%) agreed upfront with the recommendation that disease-modifying antirheumatic drug (DMARD) therapy should be started as soon as possible after diagnosis in every patient; 69 (96%) of the rheumatologists agreed with the recommendation that methotrexate (MTX) should be part of the first treatment strategy. When measuring the actual performance, it was found that the recommendation on early DMARD start was met in 253 (67%) of the recorded patients, and the recommendation on MTX in 225 (60%) of the recorded patients. Of the participants, 60 (83%) agreed that composite measures should be recorded regularly, but only in 134(54%) of the patients were composite scores actually recorded in ≥50% of patient visits. Conclusion Reporting to be compliant with EULAR recommendations and T2T principles, even after dedicated education does not mean they actually comply with it in clinical practice.
- Published
- 2016
46. Association of the different types of radiographic damage with physical function in patients with rheumatoid arthritis: analysis of the RAPID trials
- Author
-
Sofia Ramiro, Désirée van der Heijde, Robert Landewé, Carina Mihai, and A.M. Gherghe
- Subjects
0301 basic medicine ,musculoskeletal diseases ,medicine.medical_specialty ,Epidemiology ,Radiography ,Immunology ,Rheumatoid Arthritis ,Wrist ,Physical function ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Immunology and Allergy ,In patient ,030203 arthritis & rheumatology ,business.industry ,Cartilage ,medicine.disease ,Sharp score ,030104 developmental biology ,medicine.anatomical_structure ,Outcomes research ,Rheumatoid arthritis ,Joint damage ,Physical therapy ,business - Abstract
Objectives To evaluate the separate effects of erosions (E) (bone damage), joint space narrowing (JSN) (cartilage loss) and (sub)luxation (SLUX) (soft tissue damage) in four different joint groups on physical disability in rheumatoid arthritis (RA). Methods 3-year follow-up data from the Rheumatoid Arthritis PreventIon of structural Damage (RAPID) 1 and 2 trials were used. These randomised controlled trials compared certolizumab plus methotrexate (MTX) versus MTX in patients with RA. Physical function was measured by Health Assessment Questionnaire (HAQ). Radiographic damage was measured by the van der Heijde-modified Sharp score; separate scores for E, JSN and SLUX were available. Generalised estimating equations were performed to assess the relationship between HAQ and E, JSN and SLUX scores, separately and in all joint groups. Results In separate models for each type of damage and after adjusting for age, gender, baseline disease activity and treatment group, E and JSN were more strongly associated with HAQ than with SLUX. In combined models, JSN was the only type of lesion associated with HAQ when all joints were included together. When separate joint groups were analysed, E in the wrist and JSN in the metacarpophalangeal joints (MCPs) were most strongly associated with function. Conclusions Among RA-related joint damage, cartilage loss quantified by JSN is an important determinant of physical function. However, when analysing joint groups separately, erosive damage in the wrist and JSN in the MCPs had the most important influence on disability. These data indicate that the comprehensive assessment of joint damage is needed to reliably reflect disease-related damage.
- Published
- 2016
47. Validity of the rheumatoid arthritis MRI score applied to the forefeet using the OMERACT filter: a systematic literature review
- Author
-
Monique Reijnierse, Désirée van der Heijde, Annette H M van der Helm-van Mil, and Yousra J Dakkak
- Subjects
rheumatoid arthritis ,musculoskeletal diseases ,medicine.medical_specialty ,Immunology ,03 medical and health sciences ,0302 clinical medicine ,systematic review ,Rheumatology ,Internal medicine ,Synovitis ,medicine ,magnetic resonance imaging ,Immunology and Allergy ,030212 general & internal medicine ,Reliability (statistics) ,030203 arthritis & rheumatology ,Tenosynovitis ,business.industry ,Construct validity ,medicine.disease ,Clinical trial ,Systematic review ,Rheumatoid arthritis ,forefoot ,Physical therapy ,business - Abstract
ObjectiveMRI depicts inflammation and structural damage in rheumatoid arthritis (RA). The validity of MRI-scoring of wrist-joints and metacarpophalangeal-joints according to the RA MRI score(RAMRIS) has been demonstrated. The Outcomes in Rheumatology Clinical Trials (OMERACT) RAMRIS Working Group recently called for validation of the RAMRIS of the metatarsophalangeal (MTP)-joints. Therefore, a systematic literature review was performed to test if the RAMRIS applied to the MTP-joints meets the OMERACT Filter of Truth, Discrimination and Feasibility.MethodsMedical literature databases up to January 2018 were systematically reviewed for studies reporting on RAMRIS applied to MRI of the MTP-joints in RA. To be included, an article had to contain at least one MRI-feature (synovitis, bone marrow oedema (BME), tenosynovitis, erosion, joint space narrowing (JSN)) and one item from the OMERACT Filter: Truth (face, content and construct validity), Discrimination (test-retest reliability, ability to discriminate in trials, longitudinal construct validity and thresholds of meaning) and Feasibility.ResultsOf the 749 retrieved studies, 13 were included, of which 9 provided data on construct validity, 4 on discrimination (3 on reliability, 2 on longitudinal construct validity and 1 on ability to discriminate in trials) and none on feasibility. Construct validity was suggested for BME and erosions, but lacking for synovitis, tenosynovitis and JSN. Data for discrimination remain to be developed for all outcomes.ConclusionAccording to the OMERACT Filter, the validity of the RAMRIS of the forefeet is insufficient in different aspects. A research agenda was determined.
- Published
- 2018
- Full Text
- View/download PDF
48. Uncovering the heterogeneity of disease impact in axial spondyloarthritis: bivariate trajectories of disease activity and quality of life
- Author
-
Filip Van den Bosch, Astrid van Tubergen, Valéria Lima Passos, F. Wink, Robert Landewé, Anneke Spoorenberg, Maike S. V. Imkamp, Désirée van der Heijde, Annelies Boonen, Sofia Ramiro, Suzanne Arends, Maxime Dougados, Clinical Immunology and Rheumatology, AII - Inflammatory diseases, RS: CAPHRI - R1 - Ageing and Long-Term Care, FHML Methodologie & Statistiek, Interne Geneeskunde, MUMC+: MA Reumatologie (9), RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, and Translational Immunology Groningen (TRIGR)
- Subjects
medicine.medical_specialty ,Immunology ,Disease ,Bivariate analysis ,VALIDATION ,Disease activity ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Fibromyalgia ,Internal medicine ,Spondyloarthritis ,Medicine and Health Sciences ,medicine ,trajectories ,CRITERIA ,Immunology and Allergy ,030212 general & internal medicine ,Axial spondyloarthritis ,FIBROMYALGIA ,group-based multi-trajectory modelling ,030203 arthritis & rheumatology ,Ankylosing spondylitis ,business.industry ,ANKYLOSING-SPONDYLITIS ,axial spondyloarthritis ,medicine.disease ,health-related quality of life ,Cohort ,ACTIVITY SCORE ASDAS ,Analysis of variance ,business ,disease activity - Abstract
ObjectiveThe goal of managing axial spondyloarthritis (axSpA) is to improve and maintain patients’ health-related quality of life (HRQoL), mainly through targeting towards low disease activity. Here, we aim to gain insight into the joint evolution of HRQoL and disease activity by identifying and characterising latent subgroups of patients with longstanding disease displaying similar trajectories throughout 8 years of follow-up.MethodsData from Outcome in Ankylosing Spondylitis (AS) International Study (n=161) and Groningen Leeuwarden AS cohort (n=264) were used. Biennially, HRQoL was assessed by AS Quality of Life (ASQoL) and disease activity by AS Disease Activity Score—C reactive protein (ASDAS-CRP). Bivariate trajectories of these outcomes were estimated by group-based trajectory modelling. Next, trajectories were profiled by comparing the latent groups with respect to baseline factors using analysis of variance and χ² test.ResultsFive bivariate trajectories were distinguished, in which ASQoL and ASDAS-CRP were tightly linked: (t1) low impact of disease; (t2) moderate impact; (t3) high impact with major improvement; (t4) high impact with some improvement; (t5) very high impact. Profiling revealed, for example, that (t1) was characterised by male gender and Human Leucocyte Antigen B27 positivity; (t3) by younger age, shorter symptom duration and biological intake and (t5) by the highest proportion of females.ConclusionsWe identified five bivariate trajectories of HRQoL and disease activity demonstrating a clear mutual relationship. The profiles revealed that both individual-related and disease-related features define the type of disease course in respect to HRQoL and disease activity in axSpA. This may provide clinicians insight into the differences among patients and help in the management of the disease.
- Published
- 2018
- Full Text
- View/download PDF
49. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis
- Author
-
Alice B. Gottlieb, Roy Fleischmann, Luke Peterson, Désirée van der Heijde, Oliver FitzGerald, Dafna D. Gladman, Bengt Hoepken, Atul Deodhar, Jürgen Wollenhaupt, Oscar Irvin-Sellers, Majed Khraishi, Lars Bauer, Anthony M. Turkiewicz, and Philip J. Mease
- Subjects
030203 arthritis & rheumatology ,medicine.medical_specialty ,business.industry ,Immunology ,Enthesitis ,Placebo-controlled study ,Arthritis ,medicine.disease ,Placebo ,Dactylitis ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,Psoriasis Area and Severity Index ,Internal medicine ,medicine ,Immunology and Allergy ,Certolizumab pegol ,medicine.symptom ,business ,medicine.drug - Abstract
Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years’ certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years’ treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.
- Published
- 2018
- Full Text
- View/download PDF
50. Lifestyle factors may modify the effect of disease activity on radiographic progression in patients with ankylosing spondylitis: a longitudinal analysis
- Author
-
Maxime Dougados, Sofia Ramiro, Robert Landewé, Carmen Stolwijk, Filip Van den Bosch, Annelies Boonen, Astrid van Tubergen, Désirée van der Heijde, Interne Geneeskunde, RS: CAPHRI School for Public Health and Primary Care, and RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation
- Subjects
medicine.medical_specialty ,Radiography ,Ankylosing Spondylitis ,Immunology ,Disease activity ,Rheumatology ,Internal medicine ,Spondyloarthritis ,medicine ,Medicine and Health Sciences ,Immunology and Allergy ,In patient ,Disease Activity ,Socioeconomic status ,Ankylosing spondylitis ,biology ,business.industry ,C-reactive protein ,medicine.disease ,3. Good health ,Lifestyle factors ,Outcomes research ,Physical therapy ,biology.protein ,business - Abstract
Objectives: To investigate the complex relationship between inflammation, mechanical stress and radiographic progression in patients with ankylosing spondylitis (AS), using job type as a proxy for continuous mechanical stress.Methods: Patients from the Outcome in Ankylosing Spondylitis International Study were followed up for 12 years, with 2-yearly assessments. Two readers independently scored the X-rays according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Disease activity was assessed by the AS Disease Activity Score C reactive protein (ASDAS-CRP). The relationship between ASDAS and spinal radiographic progression was investigated with longitudinal analysis, with job type at baseline (physically demanding ('blue-collar') versus sedentary ('white-collar') labour) as a potential factor influencing this relationship. The effects of smoking status and socioeconomic factors were also investigated.Results: In total, 184 patients were included in the analyses (70% males, 83% human leucocyte antigen-B27 positive, 39% smokers, 48% blue-collar workers (65/136 patients in whom data on job type were available)). The relationship between disease activity and radiographic progression was significantly and independently modified by job type: In 'blue-collar' workers versus 'white-collar' workers, every additional unit of ASDAS resulted in an increase of 1.2 versus 0.2 mSASSS-units/2-years (p=0.014 for the difference between blue-collar and white-collar workers). In smokers versus non-smokers, every additional unit of ASDAS resulted in an increase of 1.9 versus 0.4 mSASSS-units/2-years.Conclusions: Physically demanding jobs may amplify the potentiating effects of inflammation on bone formation in AS. Smoking and socioeconomic factors most likely confound this relationship and may have separate effects on bone formation.
- Published
- 2015
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.