OBJECTIVES:To compare machine learning (ML) to traditional models to predict radiographic progression in patients with early axial spondyloarthritis (axSpA).METHODS:We carried out a prospective... Show moreOBJECTIVES:To compare machine learning (ML) to traditional models to predict radiographic progression in patients with early axial spondyloarthritis (axSpA).METHODS:We carried out a prospective French multicentric DESIR cohort study with 5 years of follow-up that included patients with chronic back pain for <3 years, suggestive of axSpA. Radiographic progression was defined as progression at the spine (increase of at least 1 point of mSASSS scores/2 years) or at the sacroiliac joint (worsening of at least one grade of the mNY score between 2 visits). Statistical analyses were based on patients without any missing data regarding the outcome and variables of interest (295 patients). Traditional modelling: we performed a multivariate logistic regression model (M1); then variable selection with stepwise selection based on Akaike Information Criterion (stepAIC) method (M2), and Least Absolute Shrinkage and Selection Operator (LASSO) method (M3). ML modelling: using “SuperLearner” package on R, we modelled radiographic progression with stepAIC, LASSO, random forest, Discrete Bayesian Additive Regression Trees Samplers (DBARTS), Generalized Additive Models (GAM), multivariate adaptive polynomial spline regression (polymars), Recursive Partitioning And Regression Trees (RPART) and Super Learner. Accuracy of these models was compared based on their 10-fold cross-validated AUC (cv-AUC).RESULTS:10-fold cv-AUC for traditional models were 0.79 and 0.78 for M2 and M3, respectively. The three best models in the ML algorithms were the GAM, the DBARTS and the Super Learner models, with 10-fold cv-AUC of: 0.77, 0.76 and 0.74, respectively.CONCLUSIONS:Two traditional models predicted radiographic progression as good as the eight ML models tested in this population. Show less
Magnetic resonance imaging (MRI) of the axial skeleton, spine, and sacroiliac (SI) joints is critical for the early detection and follow-up of inflammatory rheumatologic disorders such as axial... Show moreMagnetic resonance imaging (MRI) of the axial skeleton, spine, and sacroiliac (SI) joints is critical for the early detection and follow-up of inflammatory rheumatologic disorders such as axial spondyloarthritis, rheumatoid arthritis, and SAPHO/CRMO (synovitis, acne, pustulosis, hyperostosis, and osteitis/chronic recurrent multifocal osteomyelitis). To offer a valuable report to the referring physician, disease-specific knowledge is essential. Certain MRI parameters can help the radiologist provide an early diagnosis and lead to effective treatment. Awareness of these hallmarks may help avoid misdiagnosis and unnecessary biopsies. A bone marrow edema-like signal plays an important role in reports but is not disease specific. Age, sex, and history should be considered in interpreting MRI to prevent overdiagnosis of rheumatologic disease. Differential diagnoses-degenerative disk disease, infection, and crystal arthropathy-are addressed here. Whole-body MRI may be helpful in diagnosing SAPHO/CRMO. Show less
To detail the unmet clinical and scientific needs in the field of rheumatology. After a 2-year hiatus due to the SARS-CoV-2 pandemic, the 22nd annual international Advances in Targeted Therapies... Show moreTo detail the unmet clinical and scientific needs in the field of rheumatology. After a 2-year hiatus due to the SARS-CoV-2 pandemic, the 22nd annual international Advances in Targeted Therapies meeting brought together more than 100 leading basic scientists and clinical researchers in rheumatology, immunology, epidemiology, molecular biology and other specialties. Breakout sessions were convened with experts in five rheumatological disease-specific groups including: rheumatoid arthritis (RA), psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus and connective tissue diseases (CTDs). In each group, experts were asked to identify and prioritise current unmet needs in clinical and translational research, as well as highlight recent progress in meeting formerly identified unmet needs. Clinical trial design innovation was emphasised across all disease states. Within RA, developing therapies and trials for refractory disease patients remained among the most important identified unmet needs and within lupus and spondyloarthritis the need to account for disease endotypes was highlighted. The RA group also identified the need to better understand the natural history of RA, pre-RA states and the need ultimately for precision medicine. In CTD generally, experts focused on the need to better identify molecular, cellular and clinical signals of early and undifferentiated disease in order to identify novel drug targets. There remains a strong need to develop therapies and therapeutic strategies for those with treatment-refractory disease. Increasingly it is clear that we need to better understand the natural history of these diseases, including their 'predisease' states, and identify molecular signatures, including at a tissue level, which can facilitate disease diagnosis and treatment. As these unmet needs in the field of rheumatic diseases have been identified based on consensus of expert clinicians and scientists in the field, this document may serve individual researchers, institutions and industry to help prioritise their scientific activities. Show less
Kwan, Y.H.; Phang, J.K.; Woon, T.H.; Liew, J.W.; Dubreuil, M.; Proft, F.; ... ; Fong, W. 2023
Background: The use of social media in health care may serve as a beneficial tool for education, information dissemination, telemedicine, research, networking, and communications. To better... Show moreBackground: The use of social media in health care may serve as a beneficial tool for education, information dissemination, telemedicine, research, networking, and communications. To better leverage the benefits of social media, it is imperative to understand the patterns of its use and potential barriers to its implementation in health care. A previous study in 2016 that investigated social media use among young clinical rheumatologists (<= 45 years) and basic scientists showed that there was substantial social media use among them for social and professional reasons. However, there is a limited inquiry into social media use in different areas of rheumatology, such as spondyloarthritis. Objective: We aimed to explore the motivations, barriers, and patterns of social media use among an international group of experts in spondyloarthritis. Methods: We distributed a web-based survey via email from March 2021 to June 2021 to 198 members of the Assessment of Spondyloarthritis International Society. It contained 24 questions about demographic characteristics, patterns of current social media use, and perceptions of utility. Univariable and multivariable logistic regression analyses were performed to identify the characteristics associated with use trends. Results: The response rate was 78.8% (156/198). Of these, 93.6% (146/156) of participants used at least one social media platform. Apart from internet-based shopping and entertainment, the use of social media for clinical updates (odds ratio [OR] 6.25, 95% CI 2.43-16.03) and research updates (OR 3.45, 95% CI 1.35-8.78) were associated with higher social media consumption. Among the respondents, 66% (103/156) used social media in a work-related manner. The use of social media for new web-based resources (OR 6.55, 95% CI 2.01-21.37), interaction with international colleagues (OR 4.66, 95% CI 1.21-17.90), and establishing a web-based presence (OR 4.05, 95% CI 1.25-13.13) were associated with higher levels of consumption for work-related purposes. Time investment, confidentiality concerns, and security concerns were the top 3 challenges to a wider adoption of social media. Conclusions: Most respondents (103/156, 66%) use social media in a work-related manner. Professional development, establishing a web-based presence, and international collaboration were associated with higher use. Challenges to social media adoption should be addressed to maximize its benefits. Show less
Kwan, Y.H.; Phang, J.K.; Woon, T.H.; Liew, J.W.; Dubreuil, M.; Proft, F.; ... ; Fong, W. 2023
Background: The use of social media in health care may serve as a beneficial tool for education, information dissemination, telemedicine, research, networking, and communications. To better... Show moreBackground: The use of social media in health care may serve as a beneficial tool for education, information dissemination, telemedicine, research, networking, and communications. To better leverage the benefits of social media, it is imperative to understand the patterns of its use and potential barriers to its implementation in health care. A previous study in 2016 that investigated social media use among young clinical rheumatologists (≤45 years) and basic scientists showed that there was substantial social media use among them for social and professional reasons. However, there is a limited inquiry into social media use in different areas of rheumatology, such as spondyloarthritis.Objective: We aimed to explore the motivations, barriers, and patterns of social media use among an international group of experts in spondyloarthritis.Methods: We distributed a web-based survey via email from March 2021 to June 2021 to 198 members of the Assessment of Spondyloarthritis International Society. It contained 24 questions about demographic characteristics, patterns of current social media use, and perceptions of utility. Univariable and multivariable logistic regression analyses were performed to identify the characteristics associated with use trends.Results: The response rate was 78.8% (156/198). Of these, 93.6% (146/156) of participants used at least one social media platform. Apart from internet-based shopping and entertainment, the use of social media for clinical updates (odds ratio [OR] 6.25, 95% CI 2.43-16.03) and research updates (OR 3.45, 95% CI 1.35-8.78) were associated with higher social media consumption. Among the respondents, 66% (103/156) used social media in a work-related manner. The use of social media for new web-based resources (OR 6.55, 95% CI 2.01-21.37), interaction with international colleagues (OR 4.66, 95% CI 1.21-17.90), and establishing a web-based presence (OR 4.05, 95% CI 1.25-13.13) were associated with higher levels of consumption for work-related purposes. Time investment, confidentiality concerns, and security concerns were the top 3 challenges to a wider adoption of social media.Conclusions: Most respondents (103/156, 66%) use social media in a work-related manner. Professional development, establishing a web-based presence, and international collaboration were associated with higher use. Challenges to social media adoption should be addressed to maximize its benefits. Show less
Webers, C.; Kiltz, U.; Braun, J.; Heijde, D. van der; Boonen, A. 2022
Objective To investigate the effect of pharmacological treatment of SpA on depressive symptoms and explore whether this effect differs between drug classes. Methods Data from the observational... Show moreObjective To investigate the effect of pharmacological treatment of SpA on depressive symptoms and explore whether this effect differs between drug classes. Methods Data from the observational Assessment of SpondyloArthritis international Society Health Index Validation Study were used. Patients were assessed at baseline and after initiation of NSAIDs/conventional synthetic DMARDs (csDMARDs)/TNF inhibitors (TNFis). Depressive symptoms were assessed with the Hospital Anxiety and Depression Scale depression subscale [HADS-D; 0-21 (best-worst)]. Covariables included demographics and disease characteristics, including disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)/BASDAI]. The change in HADS-D from baseline was compared between treatments (NSAIDs/csDMARDs/TNFis) with analysis of variance and multivariable regression analysis. Results A total of 304 patients were included; 102/45/157 initiated NSAIDs/csDMARDs/TNFis and 260 (85%) / 44 (15%) had axial/peripheral SpA. At baseline, the mean HADS-D was 6.9 (s.d. 4.2); 126 (42%) were possibly depressed (HADS-D >= 8) and 66 (22%) were probably depressed (HADS-D >= 11). At follow-up, depressive symptoms significantly improved in all treatment groups. In multivariable regression without disease activity measures, initiating TNFis compared with NSAIDs was associated with greater improvement in depressive symptoms [beta = -1.27 (95% CI -2.23, -0.32)] and lower odds of possible depression at follow-up [odds ratio 0.47 (95% CI 0.23, 0.94)]. This association was attenuated after additional adjustment for disease activity (ASDAS/BASDAI) but not CRP. csDMARDs did not differ from NSAIDs regarding their effect on HADS-D. Between-drug class results were confirmed in axial SpA (axSpA), although less clear in peripheral SpA. Conclusion Treatment of active SpA also improves depressive symptoms. Especially in axSpA, TNFis have a greater effect than NSAIDs, which is mainly explained by a stronger effect on disease activity. We found no evidence for a direct link between CRP-mediated inflammation and depressive symptoms in SpA. Show less
Kiltz, U.; Boonen, A.; Heijde, D. van der; Bautista-Molano, W.; Vargas, R.B.; Chiowchanwisawakit, P.; ... ; Braun, J. 2022
Objective: To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health... Show moreObjective: To describe the development of an Environmental contextual factors (EF) Item Set (EFIS) accompanying the disease specific Assessment of SpondyloArthritis international Society Health Index (ASAS HI). Method: First, a candidate item pool was developed by linking items from existing questionnaires to 13 EF previously selected for the International Classification of Functioning, Disability and Health (ICF) /ASAS Core Set. Second, using data from two international surveys, which contained the EF item pool as well as the items from the ASAS HI, the number of EF items was reduced based on the correlation between the item and the ASAS HI sum score combined with expert opinion. Third, the final English EFIS was translated into 15 languages and cross-culturally validated. Results: The initial item pool contained 53 EF addressing four ICF EF chapters: products and technology (e1), support and relationship (e3), attitudes (e4) and health services (e5). Based on 1754 responses of axial spondyloarthritis patients in an international survey, 44 of 53 initial items were removed based on low correlations to the ASAS HI or redundancy combined with expert opinion. Nine items of the initial item pool (range correlation 0.21-0.49) form the final EFIS. The EFIS was translated into 15 languages and field tested in 24 countries. Conclusions: An EFIS is available complementing the ASAS HI and helps to interpret the ASAS HI results by gaining an understanding of the interaction between a health condition and contextual factors. The EFIS emphasizes the importance of support and relationships, as well as attitudes of the patient and health services in relation to self-reported health. Show less
Objectives: Paternal preconception health is recognized as an important contributor to pregnancy outcomes. Nonetheless, pregnancy outcomes of partners of men with inflammatory arthritis (IA) have... Show moreObjectives: Paternal preconception health is recognized as an important contributor to pregnancy outcomes. Nonetheless, pregnancy outcomes of partners of men with inflammatory arthritis (IA) have never been studied. Our objective was to describe the pregnancy outcomes of partners of men diagnosed with IA. Methods: We performed a multicentre cross-sectional retrospective study conducted in the Netherlands. Men with IA who were over 40 years old that reported at least one positive pregnancy test were included. To analyse the impact of IA on pregnancy outcomes, pregnancies were classified into two groups: pregnancies conceived after the diagnosis of IA and before the diagnosis of IA. Results: In total, 408 male participants diagnosed with IA reported 897 singleton pregnancies that resulted in 794 live births. Pregnancies conceived after the diagnosis of IA had higher rate of miscarriage (12.27 vs 7.53%, P = <0.05). This increased risk was still present after adjusting for confounders [OR 2.03 (95% CI 1.12, 3.69) P = 0.015]. Conclusions: This is the largest study to describe the pregnancy outcomes of partners of men diagnosed with IA and the first to demonstrate that paternal IA is associated with a higher risk of miscarriage. Notwithstanding, the overall rate of miscarriage reported in our study could be comparable to previously reported population estimates. Show less
Poddubnyy, D.; Baraliakos, X.; Bosch, F. van den; Braun, J.; Coates, L.C.; Chandran, V.; ... ; Gladman, D.D. 2021
Background: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of... Show moreBackground: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.Design: Prospective, multicenter, multinational, cross-sectional study.Methods and analyses: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of <= 10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information.Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients. Show less
Objectives. To determine quantitative SI joint MRI lesion cut-offs that optimally define a positive MRI for inflammatory and structural lesions typical of axial SpA (axSpA) and that predict... Show moreObjectives. To determine quantitative SI joint MRI lesion cut-offs that optimally define a positive MRI for inflammatory and structural lesions typical of axial SpA (axSpA) and that predict clinical diagnosis.Methods. The Assessment of SpondyloArthritis international Society (ASAS) MRI group assessed MRIs from the ASAS Classification Cohort in two reading exercises where (A) 169 cases and 7 central readers; (B) 107 cases and 8 central readers. We calculated sensitivity/specificity for the number of SI joint quadrants or slices with bone marrow oedema (BME), erosion, fat lesion, where a majority of central readers had high confidence there was a definite active or structural lesion. Cut-offs with >= 95% specificity were analysed for their predictive utility for follow-up rheumatologist diagnosis of axSpA by calculating positive/negative predictive values (PPVs/NPVs) and selecting cut-offs with PPV >= 95%.Results. Active or structural lesions typical of axSpA on MRI had PPVs >= 95% for clinical diagnosis of axSpA. Cut-offs that best reflected a definite active lesion typical of axSpA were either >= 4 SI joint quadrants with BME at any location or at the same location in >= 3 consecutive slices. For definite structural lesion, the optimal cut-offs were any one of >= 3 SI joint quadrants with erosion or >= 5 with fat lesions, erosion at the same location for >= 2 consecutive slices, fat lesions at the same location for >= 3 consecutive slices, or presence of a deep (i.e. >1 cm depth) fat lesion.Conclusion. We propose cut-offs for definite active and structural lesions typical of axSpA that have high PPVs for a long-term clinical diagnosis of axSpA for application in disease classification and clinical research. Show less
Heijde, D. van der; Dougados, M.; Maksymowych, W.P.; Bergman, G.; Curtis, S.P.; Tzontcheva, A.; ... ; Sieper, J. 2021
ObjectivesWe report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis ... Show moreObjectivesWe report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis (nr-axSpA).MethodsPatients [both GLM- and placebo (PBO)-treated in the double-blind phase] received GLM 50 mg every 4 weeks during the OLE (36-week treatment; additional 8-week safety follow-up; GLM/GLM and PBO/GLM groups). All patients who entered and received ≥1 dose of study treatment in the OLE were included in the efficacy and safety analyses. The primary efficacy evaluations were the proportions of patients achieving 20% and 40% improvement in the ASAS criteria (ASAS20 and ASAS40, respectively). Responders’ analyses were calculated using a non-responder imputation approach.ResultsOf 198 patients randomised, 189/198 (95.5%) entered the OLE; 174/198 patients (87.9%) completed all visits. Although the proportion of responders increased from week 16 to week 52 in the OLE in both GLM/GLM and PBO/GLM groups, the GLM/GLM group had a higher proportion of responders than the PBO/GLM group throughout the OLE from week 16 to week 52 (ASAS20: 71.1% to 83.9% vs 40.0% to 75.0%, respectively; ASAS40: 56.7% to 76.3% vs 23.0% to 59.4%, respectively; ASAS partial remission: 33.0% to 53.8% and 18.0% to 45.8%). In the OLE, the overall incidence of AEs was lower in the GLM/GLM vs PBO/GLM groups (41.9% and 54.2%).ConclusionsSustained improvement in clinical efficacy was observed at 52 weeks in patients with nr-axSpA following GLM treatment. GLM was well tolerated and provided substantial long-term benefits to patients with nr-axSpA. Show less
Hirano, F.; Heijde, D. van der; Gaalen, F.A. van; Landewe, R.B.M.; Gaujoux-Viala, C.; Ramiro, S. 2021
Objectives. To investigate the determinants of patient well-being over time, and the influence of age, gender and education in patients with early axial spondyloarthritis (axSpA).Methods. Five-year... Show moreObjectives. To investigate the determinants of patient well-being over time, and the influence of age, gender and education in patients with early axial spondyloarthritis (axSpA).Methods. Five-year data from DESIR, a cohort of early axSpA, were analysed. The outcome was the BAS-G over 5 years. Generalized estimating equations (GEE) were used to test the relationship between potential explanatory variables from five outcome domains (disease activity, physical function, spinal mobility, structural damage and axial inflammation) and BAS-G over time. Longitudinal relationships were analysed using an autoregressive GEE model. Age, gender and educational level were tested as effect modifiers or confounders.Results. A total of 708 patients were included. Higher BASDAI questions on fatigue [beta (95% CI): 0.17 (0.13, 0.22)], back pain [0.51 (0.46, 0.56)], peripheral joint pain [0.08 (0.04, 0.12)] and severity of morning stiffness [0.08 (0.03-0.13)], and higher BASFI [0.14 (0.08, 0.19)] were associated with a higher BAS-G. In the autoregressive model, the same variables except for morning stiffness were associated with a worsening in BAS-G. Age, gender and educational level were neither effect modifiers nor confounders.Conclusion. A higher level of back pain is associated with a worsening of patient well-being, as are, though to a lesser extent, higher levels of fatigue, peripheral joint pain and physical disability. Age, gender and educational level do not have an impact on these relationships. Show less
Stal, R.; Gaalen, F. van; Sepriano, A.; Braun, J.; Reijnierse, M.; Berg, R. van den; ... ; Baraliakos, X. 2020
Objectives. To evaluate the occurrence and progression of facet joint ankylosis in the whole spine using low-dose CT (IdCT) in radiographic axial spondyloarthritis (r-axSpA) and compare progression... Show moreObjectives. To evaluate the occurrence and progression of facet joint ankylosis in the whole spine using low-dose CT (IdCT) in radiographic axial spondyloarthritis (r-axSpA) and compare progression of facet joint ankylosis and syndesmophytes.Methods. Patients with r-axSpA from the Sensitive Imaging in Ankylosing Spondylitis (SIAS) cohort underwent IdCT at baseline (n = 6 0) and 2 years (n = 53) . Facet joints (right and left, levels C2-S1) were scored as ankylosed, not ankylosed or unable to assess. Joints that were frequently poorly visible (>15% missing), were excluded. Interreader reliability on the patient level was assessed with intraclass correlation coefficients (ICCs) and smallest detectable change (SDC). Ankylosis was assessed at joint level and patient level for both timepoints. Syndesmophytes were assessed with CT syndesmophyte score.Results. Levels C5-T2 were difficult to assess and excluded from all further analyses. Facet joint ICCs were good to excellent for status scores (0.72-0.93) and poor to excellent for progression scores (0.10-0.91). Facet joint ankylosis was detected at every level but most frequently in the thoracic joints. In total, 48% of patients showed 2-year progression. Most progression occurred in the thoracic segment. Using SDCs as cutoff, 18% of patients had progression of facet joint ankylosis only, whereas 20% of patients had progression of syndesmophytes only.Conclusion. This is the first study evaluating facet joints in the whole spine by IdCT in r-axSpA. Facet joint ankylosis was detected most often in the thoracic spine. Assessing facet joints in addition to syndesmophytes detected substantially more patients with damage progression over two years. Show less
Lunteren, M. van; Landewe, R.; Fongen, C.; Ramonda, R.; Heijde, D. van der; Gaalen, F.A. van 2020
Objective. It is unknown if in axial spondyloarthritis (axSpA) patients' illness perceptions and coping strategies change when disease activity changes.Methods. Patients diagnosed with axSpA and... Show moreObjective. It is unknown if in axial spondyloarthritis (axSpA) patients' illness perceptions and coping strategies change when disease activity changes.Methods. Patients diagnosed with axSpA and with 1 or more follow-up visits (1 and/or 2 yrs in the SPACE cohort) were included. Mixed linear models were used for illness perceptions (range 1-5), coping (range 1-4), back pain (numeric rating scale range 0-10), health-related quality of life (range 0-100), physical and mental component summary (PCS and MCS; range 0-100), work productivity loss (WPL; range 0-100), and activity impairment (AI; range 0-100%), separately, to test if they changed over time.Results. At baseline, 150 axSpA patients (mean age 30.4 yrs, 51% female, 65% HLA-B27+) had a mean (SD) numeric rating scale back pain of 4.0 (2.5), PCS of 28.8 (14.0), MCS of 47.8 (12.4), WPL of 34.1% (29.8), and AI of 38.7% (27.9). Over 2 years, clinically and statistically significant improvements were seen in the proportion of patients with an Ankylosing Spondylitis Disease Activity Score (ASDAS) of low disease activity (from 39% at baseline to 68% at 2 years), back pain (-1.5, SD 2.2), AI (-14.4%, SD 27.2), PCS (11.1, SD 13.3), and WPL (-15.3%, SD 28.7), but MCS did not change (0.7, SD 13.9; P = 0.201). In contrast, illness perceptions and coping strategies did not change over a period of 2 years. For example, at 2 years patients believed that their illness had severe "consequences" (2.8, SD 0.9) and they had negative emotions (e.g., feeling upset or fear) towards their illness ["emotional representation", 2.5 (0.8)]. Patients most often coped with their pain by putting pain into perspective ["comforting cognitions", 2.8 (0.6)] and tended to cope with limitations by being optimistic ["optimism", 2.9 (0.7)].Conclusion. While back pain, disease activity, and health outcomes clearly improved over 2 years, illness perceptions and coping strategies remained remarkably stable. Show less
Chandran, V.; Heijde, D. van der; Fleischmann, R.M.; Lespessailles, E.; Helliwell, P.S.; Kameda, H.; ... ; Gallo, G. 2020
Objective. The aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients.Methods. In a phase III study, patients naive to biologic... Show moreObjective. The aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients.Methods. In a phase III study, patients naive to biologic treatment were randomized to placebo, adalimumab 40 mg every 2 weeks (ADA; active reference) or ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after an initial dose of 160 mg. At week 24 (week 16 for inadequate responders), ADA (after 8-week washout) and placebo patients were re-randomized to IXEQ2W or IXEQ4W. Outcomes were evaluated using a modified non-responder imputation [linear extrapolation for radiographic progression (modified total Sharp score = 0)] during extended treatment until week 156.Results. Of 417 patients, 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study. Incidence rates of treatment-emergent and serious adverse events, respectively, were 38.0 and 5.2 with IXEQ2W (n =189) and 38.1 and 8.0 with IXEQ4W (n =197). One death occurred (IXEQ4W). With IXEQ2W and IXEQ4W, respectively, the response rates persisted to week 156 as measured by the ACR response >= 20% (62.5 and 69.8%), >= 50% (56.1 and 51.8%) and >= 70% (43.8 and 33.4%), psoriasis area and severity index (PASI) 75 (69.1 and 63.5%), PASI 90 (64.5 and 51.2%) and PASI 100 (60.5 and 43.6%). Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients.Conclusion. In this 156-week study of ixekizumab, the safety profile remained consistent with previous reports, and improvements in signs and symptoms of PsA were observed, including persistent low rates of radiographic progression. Show less
Bentum, R.E. van; Vodnizza, S.E.I.; Fuente, M.P.P. de la; Aldridge, F.V.; Navarro-Compan, V.; Rusman, T.R.; ... ; Horst-Bruinsma, I.E. van der 2020
Objective. Physical function in patients with axial spondyloarthritis (axSpA) is currently evaluated through questionnaires. The Ankylosing Spondylitis Performance Index (ASPI) is a performance... Show moreObjective. Physical function in patients with axial spondyloarthritis (axSpA) is currently evaluated through questionnaires. The Ankylosing Spondylitis Performance Index (ASPI) is a performance-based measure for physical functioning, which has been validated in Dutch patients with radiographic (r-) axSpA. The interrater reliability has not yet been determined. To our knowledge, this study is the first to evaluate the validity, reliability, and feasibility of the ASPI in another patient population, including both r- and nonradiographic (nr-) axSpA patients.Methods. Patients with axSpA were recruited from rheumatology clinics in Santiago, Chile. Dutch instructions were translated to Spanish by a forward-backward procedure. Study visits were performed at baseline and 1-4 weeks later. Four ASPI observers were involved, measuring the performance times of the 3 ASPI tests. Validity was assessed through a patient questionnaire (numeric rating scale 0-10: >= 6 sufficient). For reliability, intraclass correlation coefficients (ICC) were calculated (with 95% CI). Correlations between the ASPI and disease variables were tested with regression analyses.Results. Sixty-eight patients were included (57% male, 52% r-axSpA). All patients understood the Spanish instructions and considered the ASPI to reach its aim (84%) and representativeness (85%) for physical functioning. The overall interrater (n = 62) and test-retest (n = 39) reliability (ICC) of the 3 tests combined were 0.93 (0.88-0.96) and 0.94 (0.87-0.97), respectively. Eighty-two percent of the patients completed all tests and 94% finished in < 15 min (feasibility).Conclusion. This study demonstrated a high validity and feasibility in an entirely different population, with both r-axSpA and nr- axSpA. The interrater and test-retest reliability was excellent. The ASPI instructions are now available for Spanish-speaking patients. Show less
Stolwijk, C.; Essers, I.; Bosch, F. van den; Dougados, M.; Etcheto, A.; Heijde, D. van der; ... ; ASAS-COMOSPA Study Grp 2020
Objective. To confirm validity of the Self-administered Comorbidity Questionnaire modified for patients with SpA (mSCQ), and assess whether validity improves when adding items on extra-articular... Show moreObjective. To confirm validity of the Self-administered Comorbidity Questionnaire modified for patients with SpA (mSCQ), and assess whether validity improves when adding items on extra-articular manifestations (EAMs), i.e. uveitis, psoriasis, and IBD, and osteoporosis and fractures.Methods. Data from the Assessment in SpondyloArthritis international Society COMOrbidities in SPondyloArthritis study were used. Criterion validity of presence of EAMs, osteoporosis and fractures was assessed as agreement (kappa) between patients' self-reported and physician-confirmed disease. Construct validity of the mSCQ including EAMs, osteoporosis and/or fractures (SpA-SCQ) was assessed by testing hypotheses about correlations with demographics, physical function, work ability, health utility and disease activity, and was compared with construct validity of the rheumatic disease comorbidity index.Results. In total, 3984 patients contributed to the analyses. Agreement between patient-reported and physician-reported EAMs was substantial to almost perfect (uveitis kappa = 0.81, IBD kappa = 0.73, psoriasis kappa = 0.86). Agreement for osteoporosis (kappa = 0.38) and fractures (kappa = 0.39) was fair. As hypothesized, the mSCQ correlated moderately to weakly with age, physical function, work limitations and health utility, and very weakly with disease activity. In contrast to our hypothesis, adding EAMs, osteoporosis and/or fractures to the mSCQ decreased correlations with several external constructs, especially among patients with peripheral SpA. Correlations with the different constructs were stronger for the both mSCQ and SpA-SCQ (r(BASFI) = 0.34; r(EQ-5D) = -0.33) compared with the rheumatic disease comorbidity index (r(BASFI) = 0.24; r(EQ-5D) = -0.21).Conclusion. The mSCQ is a valid self-report instrument to assess the influence of comorbidities on health outcomes in patients with SpA. Adding EAMs and/or osteoporosis or fractures does not improve validity of the mSCQ. Show less
Alegria, G.C.; Voirin-Hertz, M.; Garrigues, F.; Herbette, M.; Deloire, L.; Simon, A.; ... ; Saraux, A. 2020
Objective. Lumbosacral transitional vertebras (LSTVs) are common in the general population, but their potential impact on the sacroiliac joints is unclear. We aimed to determine the prevalence of... Show moreObjective. Lumbosacral transitional vertebras (LSTVs) are common in the general population, but their potential impact on the sacroiliac joints is unclear. We aimed to determine the prevalence of LSTVs and to assess their associations with sacroiliitis by standard radiography and MRI in a population with suspected axial spondyloarthritis.Methods. The data were from the DESIR cohort of 688 patients aged 18-50 years with inflammatory low back pain for 3 months but <3 years suggesting axial spondyloarthritis. The baseline pelvic radiographs were read by two blinded readers for the presence and type (Castellvi classification) of LSTVs. Associations between LSTVs and other variables collected at baseline and at the diagnosis were assessed using the chi(2) test (or Fisher's exact test) or the Mann-Whitney test.Results. LSTV was found in 200/688 (29.1%) patients. Castellvi type was Ia in 54 (7.8%), Ib in 76 (11.0%), IIa in 20 (2.9%), IIb in 12 (1.7%), IIIa in 7 (1.0%), IIIb in 21 (3.0%) and IV in 10 (1.4%) patients. Compared with the group without LSTVs, the group with LSTVs had higher proportions of patients meeting modified New York criteria for radiographic sacroiliitis (19% vs 27%, respectively; P = 0.013) and Assessment of SpondyloArthritis international Society MRI criteria for sacroiliitis (29% vs 39%, respectively; P = 0.019).Conclusion. In patients with inflammatory back pain suggesting axial spondyloarthritis, LSTVs are associated with both radiographic and MRI sacroiliitis. Show less
