Concordance and agreement between different activity scores in polymyalgia rheumatica.

OBJECTIVE: The C reactive protein polymyalgia rheumatica activity score (CRP-PMR-AS) is a composite index that includes CRP levels and was developed specifically for PMR. As treatments such as interleukin-6 antagonists can normalise CRP levels, the erythrocyte sedimentation rate (ESR) of PMR-AS, the clinical (clin)-PMR-AS and the imputed-CRP (imp-CRP)-PMR-AS have been developed to avoid such bias. Our primary objective was to measure the correlation of these activity scores. Our secondary objective was to evaluate the concordance between different cutoffs of the PMR-ASs. METHOD: Data from the Safety and Efficacy of tocilizumab versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence (SEMAPHORE) trial, a superiority randomised double-blind placebo-controlled trial, were subjected to post hoc analysis to compare the efficacy of tocilizumab versus placebo in patients with active PMR. The CRP-PMR-AS, ESR-PMR-AS, clin-PMR-AS and imp-CRP-PMR-AS were measured at every visit. The concordance and correlation between these scores were evaluated using kappa correlation coefficients, Bland-Altman correlations, intraclass correlation coefficients (ICCs) and scatter plots. RESULTS: A total of 101 patients were included in the SEMAPHORE trial, and 100 were analysed in this study. The correlation between the PMR-ASs was excellent, as the ICC and kappa were >0.85 from week 4 until week 24 (CRP-PMR-AS ≤10 or >10). Bland-Altman plots revealed that the differences between the CRP-PMR-AS and the other threescores were low. The cut-off values for the clin-PMR-AS were similar to those for the CRP-PMR-AS 86% of the time. CONCLUSION: The correlation between all the PMR-ASs was excellent, reflecting the low weight of CRP. In clinical trials using drugs that have an impact on CRP, the derived activity scores can be used. TRIAL REGISTRATION NUMBER: NTC02908217.

Towards the Lowest Efficacious Dose: Results From a Multicenter Noninferiority Randomized Open-Label Controlled Trial Assessing Tocilizumab or Abatacept Injection Spacing in Rheumatoid Arthritis in Remission.

OBJECTIVE: We assess the clinical and structural impact at two years of progressively spacing tocilizumab (TCZ) or abatacept (ABA) injections versus maintenance at full dose in patients with rheumatoid arthritis in sustained remission. METHODS: This multicenter open-label noninferiority (NI) randomized clinical trial included patients with established rheumatoid arthritis in sustained remission receiving ABA or TCZ at a stable dose. Patients were randomized to treatment maintenance (M) at full dose (M-arm) or progressive injection spacing (S) driven by the Disease Activity Score in 28 joints every 3 months up to biologics discontinuation (S-arm). The primary end point was the evolution of disease activity according to the Disease Activity Score in 44 joints during the 2-year follow-up analyzed per protocol with a linear mixed-effects model, evaluated by an NI test based on the one-sided 95% confidence interval (95% CI) of the slope difference (NI margin 0.25). Other end points were flare incidence and structural damage progression. RESULTS: Overall, 202 of the 233 patients included were considered for per protocol analysis (90 in S-arm and 112 in M-arm). At the end of follow-up, 16.2% of the patients in the S-arm could discontinue their biologic disease-modifying antirheumatic drug, 46.9% tapered the dose and 36.9% returned to a full dose. NI was not demonstrated for the primary outcome, with a slope difference of 0.10 (95% CI 0.10-0.31) between the two arms. NI was not demonstrated for flare incidence (difference 42.6%, 95% CI 30.0-55.1) or rate of structural damage progression at two years (difference 13.9%, 95% CI -6.7 to 34.4). CONCLUSION: The Towards the Lowest Efficacious Dose trial failed to demonstrate NI for the proposed ABA or TCZ tapering strategy.

Implementation of regulatory guidance for JAK inhibitors use in patients with immune-mediated inflammatory diseases: An international appropriateness study.

BACKGROUND AND AIMS: The Pharmacovigilance Risk Assessment Committee (PRAC) proposed measures to address severe side effects linked to Janus kinase inhibitors (JAKi) in immune-mediated inflammatory diseases (IMID). Use of these medications in individuals aged 65 and older, those at high cardiovascular risk, active or former long-term smokers, and those with increased cancer risk should be considered only if no alternatives exist. Caution is advised when administering JAKi to patients at risk of venous thromboembolism. We aim to implement recommendations from regulatory guidelines based on areas of uncertainty identified. METHODS: A two-round modified Research and Development/University of California Los Angeles appropriateness methodology study was conducted. A panel of 21 gastroenterologists, dermatologists and rheumatologists used a 9-point Likert scale to rate the appropriateness of administering a JAKi for each proposed clinical scenario. Scores for appropriateness were categorized as appropriate, uncertain, or inappropriate. Two rounds were performed, each with online surveys and a virtual meeting to enable discussion and rating of each best practice. RESULTS: Round 1 involved participants rating JAKi appropriateness and suggesting descriptors to reduce uncertainty. Survey results were discussed in a virtual meeting, identifying areas of disagreement. In round 2, participants rated their agreement with descriptors from round 1, and the level of uncertainty and disagreement reduced. Age flexibility is recommended in the absence of other risk factors. Active counseling on modifiable risks (e.g., overweight, mild hyperlipidemia and hypertension) and smoking cessation is advised. Uncertainty persists regarding cancer risk due to various factors. CONCLUSIONS: We outlined regulatory guidance without a personalized evaluation of the patient's risk profile might lead to uncertainty and become an arid technicality. Therefore, we identified gaps and implemented PRAC recommendations to help health professionals in clinical practice.

CT evaluation of bone fragility 2 years after bariatric surgery: an observational study.

INTRODUCTION: The objectives were to evaluate bone fragility on computed tomography (CT) in patients with obesity before and 2 years after bariatric surgery and to identify risk factors for a decrease in the scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1). MATERIALS AND METHODS: Patients with obesity who underwent bariatric surgery and CT before and 2 years (± 6 months) after bariatric surgery were included. SBAC-L1 was measured on CT with a fracture threshold at 145 HU. RESULTS: 78 patients were included, 85.9% women, mean age of 48.5 years (± 11.4); the mean BMI was 46.2 kg/m2 (± 7) before surgery and 29.8 kg/m2 (± 6.7) 2 years after surgery. There was a significant change in SBAC-L1 2 years after surgery (p = 0.037). In multivariate analysis, the risk factors for having an SBAC-L1 ≤ 145HU 2 years after bariatric surgery in those with an SBAC-L1 > 145HU before surgery were age and sex, with men and older patients having a higher risk (OR 32.6, CI 95% [1.86-568.77], and OR 0.85, CI 95% [0.74-0.98], respectively). CONCLUSION: SBAC-L1 was significantly lower two years after bariatric surgery. Men sex and older patients were the risk factors for having an SBAC-L1 below the fracture threshold 2 years after surgery.

Relationship between ectopic calcifications and bone fragility depicted on computed tomography scan in 70 patients with systemic sclerosis.

Background: A higher risk of osteoporotic fracture was described in systemic sclerosis patients than in healthy patients. Objective: To evaluate the relation between osteoporotic fracture risk measured by the scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1) on computed tomography (CT) scan and the presence of ectopic calcifications: vascular, valvular and spinal. Methods: This monocentric retrospective study was performed on patients followed between 2000 and 2014 at Nancy University Hospital. Systemic sclerosis patients, according to ACR/EULAR 2013 criteria, followed from 2000 to 2014 and who underwent, during their follow-up, a CT including the first lumbar vertebra were included. The SBAC-L1 was measured with a threshold set at 145 Hounsfield units (HU). Vascular and spinal calcifications were studied on CT. For vascular calcifications, the Agatston score was used. Valvular calcifications were studied on echocardiography. Results: A total of 70 patients were included (mean age: 62.3 (±15.6) years, women 88.5%). The mean SBAC-L1 was 157.26 (±52.1) HU, and 35 patients (50%) presented an SBAC-L1 ⩽ 145 HU. The reproducibility of the calcification evaluation was good, with kappa coefficients varying between 0.63 and 1. In univariate analysis, spinal and vascular calcifications were associated with an SBAC-L1 ⩽ 145 HU, with ORs of 13.6 (1.6-113.3) and 8 (95%CI: 2.5-25.5), respectively. In multivariate analysis, the SBAC-L1 was not associated with the presence of any ectopic calcifications. The SBAC-L1 decreased with age (p = 0.0001). Conclusion: Patients with systemic sclerosis with an SBAC-L1 ⩽ 145 HU were older, but they did not have more ectopic calcification. Trial registration: The ethics committee of Nancy Hospital agreed with this study (referral file number 166). This study was designed in accordance with the general ethical principles outlined in the Declaration of Helsinki.

Prevalence of Osteoporosis Assessed by DXA and/or CT in Severe Obese Patients.

The primary objective was to evaluate bone fragility prevalence on dual X-ray absorptiometry (DXA) and computed tomography (CT) in patients with severe obesity. The secondary objective was to evaluate the risk factors for bone fragility. This monocentric study was conducted in patients with grade 2 and 3 obesity. Bone mineral density (BMD) and T-score were studied on DXA, and the scanographic bone attenuation coefficient of L1 (SBAC-L1) was measured on CT. Among the 1386 patients included, 1013 had undergone both DXA and CT within less than 2 years. The mean age was 48.4 (±11.4) years, 77.6% were women, and the mean BMI was 45.6 (±6.7) kg/m². Eight patients (0.8%) had osteoporosis in at least one site. The mean SBAC-L1 was 192.3 (±52.4) HU; 163 patients (16.1%) were under the threshold of 145 HU. Older age (OR[CI95] = 1.1 [1.08-1.16]), lower BMD on the femoral neck and spine (OR[CI95] = 0.04[0.005-0.33] and OR[CI95] = 0.001[0.0001-0.008], respectively), and higher lean mass (OR[CI95] = 1.1 [1.03-1.13]) were significantly associated with an SBAC-L1 ≤ 145 HU in multivariate analysis. Approximately 16% of patients with severe obesity were under the SBAC-L1 threshold, while less than 1% were classified as osteoporotic on DXA.

Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial.

Importance: Few treatments are available for patients with glucocorticoid-dependent polymyalgia rheumatica. IL-6 antagonists may reduce disease activity in patients with active glucocorticoid-dependent polymyalgia rheumatica. Objective: To compare the efficacy of tocilizumab vs placebo in patients with glucocorticoid-dependent polymyalgia rheumatica. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial enrolled 101 patients with polymyalgia rheumatica at 17 hospitals in France from February 2017 to October 2019. Final follow-up occurred in November 2020. Inclusion criteria were persistent disease activity (polymyalgia rheumatica activity score computed using the C-reactive protein level [CRP PMR-AS] >10) and prednisone dose greater than or equal to 10 mg per day. Interventions: Patients were randomly assigned to receive intravenous tocilizumab (8 mg/kg; n = 51) or placebo (n = 50) every 4 weeks for 24 weeks, combined with predefined standardized tapering of oral prednisone. Main Outcomes and Measures: The primary efficacy end point was CRP PMR-AS less than 10 (range, 0-100; higher values indicate greater activity; no minimal clinically important difference defined) combined with either prednisone dose less than or equal to 5 mg per day or a decrease in prednisone dose greater than or equal to 10 mg from baseline at week 24. There were 11 secondary outcomes assessed at week 24 included in this report, including disease activity (measured by CRP PMR-AS) and the proportion of patients no longer taking prednisone. Results: Of the 101 randomized patients (mean age, 67.2 years; 68 [67.3%] women), 100 (99%) received at least 1 infusion and 100 completed the trial. The primary end point was achieved in 67.3% of patients in the tocilizumab group and 31.4% of patients in the placebo group (adjusted difference, 36.0% [95% CI, 19.4%-52.6%]; adjusted relative risk, 2.3 [95% CI, 1.5-3.6]; P < .001). Of 11 reported secondary end points at 24 weeks, 7 showed significant differences favoring tocilizumab, including mean CRP PMR-AS score (7.5 [95% CI, 5.4-9.6] vs 14.9 [95% CI, 11.4-18.4]; adjusted difference, -7.5 [95% CI, -11.2 to -3.8]; P < .001) and the percentage of patients no longer receiving prednisone (49.0% vs 19.6%; adjusted difference, 29.3% [95% CI, 18.9%-39.7%]; adjusted relative risk, 2.5 [95% CI, 1.8-3.5]; P < .001). The most frequent adverse events were infections, experienced by 23 patients (46.9%) in the tocilizumab group and 20 (39.2%) in the placebo group. Conclusions and Relevance: Among patients with active polymyalgia rheumatica despite prednisone therapy, tocilizumab, compared with placebo, resulted in a significantly greater percentage of patients with a CRP PMR-AS less than 10 with reduced prednisone requirements at week 24. Further research is needed to confirm efficacy and to determine the balance of potential benefits and harms. Trial Registration: ClinicalTrials.gov Identifier: NCT02908217.

Characteristics of patients with knee and/or hip osteoarthritis undergoing spa treatment: the prospective KHOALA cohort study.

Knee and hip osteoarthritis (KHOA) are a source of functional impairment. With aging, the management of osteoarthritis (OA) is a major issue in the search for improved quality of life. Spa treatment provides short- and mid-term symptom relief without serious side effects. This study aimed to identify characteristics of patients with KHOA associated with use of spa treatment. The prospective KHOALA cohort included 878 adults aged 40 to 75 years with symptomatic KHOA. We separately analyzed knee and hip OA data and compared patients who never had spa treatment with those who had at least one or multiple treatments during 5 years of follow-up in terms of socio-demographic characteristics, clinical data, quality of life (OAKHQOL, SF-36), physical activity (MAQ), functional impairment (WOMAC), and health care consumption (pharmacological and non-pharmacological treatments). Factors associated with at least one or multiple spa treatments were evaluated with regression logistic models. In all, 607 (69.1%) patients had knee OA (KOA), 222 (25.3%) hip OA (HOA) and 49 (5.6%) both, 91 (13.9%) with KOA, and 33 (12.2%) with HOA had at least one spa treatment. In the KOA cohort, the probability of at least one, two, or three spa treatments was increased with older age (odds ratio = 1.6 [95% confidence interval 1.2-2.2], 1.8 [1.2-2.8], 2.4 [1.4-4.2], respectively), greater use of physiotherapy (OR = 3.9 [2.1-7.1], 2.7 [1.3-5.6], 2.5 [1.1-5.9]), having a prosthesis (OR = 2.1 [1.2-3.8], 2.2 [1.1-4.3], 2.5 [1.1-5.5]), and low MAQ score (OR = 0.7 [0.6-0.9], 0.7 [0.5-1.0], 0.7 [0.5-1.0]). In the HOA cohort, female sex was associated with at least one (OR = 3.0 [1.1-8.0]) or two (OR = 5.1 [1.2-22.5]) spa treatments. In this cohort of KHOA, repeated spa treatment over 5 years was strongly associated with older age, greater use of physiotherapy and presence of a prothesis with KOA and female sex with HOA. This study may help to better understand spa treatment determinants in OA.

Development of a new ultrasound scoring system to evaluate glandular inflammation in Sjögren's syndrome: an OMERACT reliability exercise.

OBJECTIVE: The aim of this exercise from the OMERACT Ultrasound subgroup on Sjögren's syndrome was to develop and assess the reliability of a consensus-based semiquantitative colour Doppler US scoring system for pathologic salivary gland vascularization in patients with primary Sjögren's syndrome (pSS). METHODS: Using the Delphi method, a colour Doppler semiquantitative scoring system for vascularization of bilateral parotid and submandibular glands was developed and tested in static images and on patients (9 pSS patients and 9 sonographers). Intra-reader and inter-reader reliability of grading the salivary glands were computed by weighted Cohen and Light's kappa analysis, respectively. RESULTS: The consensus-based semiquantitative score was: grade 0, no visible vascular signals; grade 1, focal, dispersed vascular signals; grade 2, diffuse vascular signals detected in <50% of the gland; grade 3, diffuse vascular signals in >50% of the gland. In static images, the intra- and inter-reader reliability showed excellent kappa values (95% CI) of 0.90 (0.87, 0.93) and 0.80 (0.74, 0.84), respectively, for all four salivary glands together. In patients, the intra- and inter-reader reliability for all four salivary glands together was kappa = 0.84 (0.73, 0.92) and 0.70 (0.64, 0.76), respectively. CONCLUSION: The consensus-based colour Doppler US scoring for the evaluation of salivary gland vascularization in pSS showed a good inter-reader reliability and excellent intra-reader reliability in static images and in patients. The clinical application of the developed scoring system should be tested in clinical settings.

Are Three-Dimensional-Printed Foot Orthoses Able to Cover the Podiatric Physician's Needs?

BACKGROUND: Current management of foot pain requires foot orthoses (FOs) with various design features (eg, wedging, height) and specific mechanical properties (eg, hardness, volume). Development of additive manufacturing (three-dimensional [3-D] printing) raises the question of applying its technology to FO manufacturing. Recent studies have demonstrated the physical benefits of FO parts with specific mechanical properties, but none have investigated the relationship between honeycomb architecture (HcA) infilling density and Shore A hardness of thermoplastic polyurethane (TPU) used to make FOs, which is the aim of this study. METHODS: Sixteen different FO samples were made with a 3-D printer using TPU (97 Shore A), with HcA infilling density ranging from 10 to 40. The mean of two Shore A hardness measurements was used in regression analysis. RESULTS: Interdurometer reproducibility was excellent (intraclass correlation coefficient, 0.91; 95% confidence interval [CI], 0.64-0.98; P < .001) and interprinter reproducibility was excellent/good (intraclass correlation coefficient, 0.84; 95% CI, 0.43-0.96; P < .001). Linear regression showed a positive significant relationship between Shore A hardness and HcA infilling density (R2 = 0.955; P < .001). Concordance between evaluator and durometer was 86.7%. CONCLUSIONS: This study revealed a strong relationship between Shore A hardness and HcA infilling density of TPU parts produced by 3-D printing and highlighted excellent concordance. These results are clinically relevant because 3-D printing can cover Shore A hardness values ranging from 40 to 70, representing most FO production needs. These results could provide important data for 3-D manufacturing of FOs to match the population needs.

Relationship between spinal structural damage on radiography and bone fragility on CT in ankylosing spondylitis patients.

To evaluate whether the risk of bone fragility on computed tomography (CT) (scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1)) is associated with the severity of spine structural involvement (mSASSS) in patients with ankylosing spondylitis (AS). This retrospective study included AS patients, followed from 2009 to 2017, who fulfilled the New York criteria and who underwent thoraco-abdomino-pelvic CT and radiography (spine, pelvis). The structural involvement was retained for mSASSS ≥ 2. The SBAC-L1 was measured in Hounsfield units (HU). A SBAC-L1 ≤ 145 HU was used to define patients at risk of vertebral fracture (VF). A total of 73 AS patients were included (mean age: 60.3 (± 10.7) years, 8 women (11%), mean disease duration: 24.6 years (± 13.9)). Sixty patients (82.2%) had a mSASSS ≥ 2 (mean score 20.7 (± 21.2)). The mean SBAC-L1 was 141.1 HU (± 45), 138.1 HU (± 44.8) and 154.8 HU (± 44.9) in the total, mSASSS ≥ 2 and mSASSS < 2 populations, respectively. Patients with bone bridges had lower SBAC-L1 than mSASSS ≥ 2 patients without ankylosis (p = 0.02) and more often SBAC-L1 ≤ 145 HU (73% vs 41.9%, p = 0.006). A SBAC-L1 ≤ 145 HU was not associated with structural spine involvement, but patients with bone bridges had significantly decreased SBAC-L1 and an increased probability of being under the fracture threshold.

Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis.

KEY MESSAGES: No difference between both hands was observed for clinical and radiographical presentations in EHOA patients. A bilateral and symmetrical relationship was found between hand joints. HIGHLIGHTS: EHOA have symmetrical distribution and specific association in structural lesions. This study aims to analyse the preferential topographical distribution of clinical and structural lesions between the dominant and non-dominant hands in erosive hand osteoarthritis (EHOA) patients. Both hands were assessed via radiography in EHOA patients. A comparative analysis of the clinical features and structural lesions between the dominant and non-dominant hands was performed. The structural lesions were assessed according to the anatomical radiographic score of Verbruggen-Veys (VV). Next, a principal component analysis was performed to describe and highlight the relationships observed between the joints. Sixty patients were included in this study: there were 57 women, and the mean age was 66.1 (± 7.6) years. For the distal interphalangeal (DIP) joints, nodes were observed more frequently on the dominant hand (4 vs 3; p = 0.005). No difference in structural lesions was observed between the two hands except for the 2nd proximal interphalangeal (PIP) (p = 0.045). A principal component analysis with varimax rotation described relationships between the 2nd PIP, 3rd PIP, 4th PIP, 4th DIP and 5th DIP joints in both hands. No significant differences between dominant and non-dominant hands were observed for clinical and structural lesions in our sample of EHOA patients. A bilateral and symmetrical injury was observed in most EHOA joints. Trial registration Clinical trial registration number: NCT01068405.

Performance of ultrasound to assess erosion progression in rheumatoid arthritis.

OBJECTIVES: To analyse the performance of ultrasonography (US) to detect bone erosion progression at the patient level and at the joint level by the US score for erosions (USSe) in early-stage and late-stage rheumatoid arthritis (RA) over a 2-year follow-up. METHODS: Clinical and demographic information was recorded at baseline, and hands and feet RX were scored according to the Sharp erosion score. USSe was performed at baseline and over 2 years of follow-up on six bilateral joints (MCP2, 3, 5; MTP2, 3, 5). Inter-examiner reproducibility was performed on 14 patients, and the smallest detectable change (SDC) was calculated. US progression was defined as a change in USSe > SDC. RESULTS: 71 patients were included: 22 (31.0 %) early RA, and 49 (69.0 %) late RA. The intra-class correlation coefficient values of the USSe for intra- and inter-examiner studies were 0.96 (CI95: 0.93-0.98), and 0.92 (CI95: 0.75-0.97), respectively. On US, erosions prevailed at baseline in MTP5 joints followed by MCP2 and MCP5 joints. With an SDC calculated at 2.3, 28 patients (39.4 %) were classified as progressors, 30 (42.3 %) were stable, and 13 (18.3 %) were regressors during the follow-up. At the joint level, erosion progression was significant on the MCP2 and MTP5 joints in early RA (p < 0.01) and on the MCP5 and MTP5 joints for all RA (p < 0.05). CONCLUSIONS: US is a highly reproducible method that is able to detect erosion progression at the patient level for both early and late RA and at the joint level (MCP2 and MTP5) for only early RA.

Evaluation of Bone Erosions in Rheumatoid Arthritis: The Ultrasound Score for Erosions Versus the Modified Sharp/van der Heijde Score for Erosions.

OBJECTIVE: To evaluate the relationship between the UltraSound Score for Erosions (USSe) and the modified Sharp/van der Heijde score for erosions (SHSe). METHODS: One hundred eight patients with rheumatoid arthritis (RA) were included. On radiography, SHSe was evaluated by 2 or 3 blinded readers (in case of discordance). On ultrasonography, erosions were scored on 6 bilateral joints (metacarpophalangeal joints 2,3,5; metatarsophalangeal joints 2,3,5) with a 4-point scale to calculate the USSe. RESULTS: The Pearson correlation was good (r = 0.68, P < 0.001) and the agreement illustrated by a Bland-Altman plot was excellent (91%) between the 2 scores, which were complementary in detecting erosions. CONCLUSION: The USSe seems to be a valuable tool for assessing erosive damage in RA.

Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA).

OBJECTIVE: To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis. METHODS: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group). RESULTS: A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). CONCLUSION: This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity.

Secukinumab and ustekinumab treatment in psoriatic arthritis: results of a direct comparison.

OBJECTIVES: To evaluate the characteristics of patients (pts) with PsA treated by ustekinumab (UST) or secukinumab (SEK) and to compare real-world persistence of UST and SEK in PsA. METHODS: In this retrospective, national, multicentre cohort study, pts with PsA (CASPAR criteria or diagnosis confirmed by the rheumatologist) initiating UST or SEK with a follow-up ≥6 months were included from January 2011 to April 2019. The persistence between SEK and UST was assessed after considering the potential confounding factors by using pre-specified propensity-score methods. Causes of discontinuation and tolerance were also collected. RESULTS: A total of 406 pts were included: 245 with UST and 161 with SEK. The persistence rate was lower in the UST group compared with the SEK group [median persistence 9.4 vs 14.7 months; 26.4% vs 38.0% at 2 years; weighted hazard ratio (HR) = 1.42; 95% CI: 1.07, 1.92; P =0.015]. In subgroup analysis, the persistence rate of SEK associated with MTX was significantly higher than that of UST associated with MTX: HR = 2.20; 95% CI: 1.30, 3.51; P =0.001, in contrast to SEK vs UST monotherapy: HR = 1.06; 95% CI: 0.74, 1.53; P =0.75. Discontinuation due to inefficacy was reported in 91.7% (SEK) and 82.4% (UST) of pts. Discontinuation due to an adverse event was reported in 12.2% (SEK) and 7.7% (UST) of pts. CONCLUSION: In this first study comparing UST and SEK, the persistence of SEK was higher than that of UST in PsA. In subgroup analysis, this difference was only found in association with MTX.

Relationship between calcifications and structural lesions on hand radiography and axial calcifications on CT-scan: A retrospective study in systemic sclerosis.

The objectives of this study were to describe the prevalence and characteristics of radiographic lesions of the hands, and calcifications of the spine on computer tomography scans (CT-scans), and to investigate the relationships between radiographic and CT-scan abnormalities and clinical features in a population of patients with systemic sclerosis (SSc).Subjects underwent X-ray examination of the hands, and thoracic or thoraco-abdominal and pelvic CT scan or lumbar CT scan in the year. Structural lesions on hand X ray was scored and spinal calcifications were evaluated in the anterior, intracanal and posterior segments. Intra and inter-reliability was tested for radiography and CT- scan. Prognostic factors considered were interstitial pulmonary lesions on the CT scan, pulmonary arterial hypertension (PAH) and death.This study involved 77 SSc patients, 58 (75%) with limited cutaneous SSc (lcSSc) and 19 (25%) with diffuse SSc (dSSc). The prevalences of radiographic lesions of the hand were 28.6% for periarticular calcifications and 26% for calcinosis. On CT scan, 64 (83%) patients exhibited at least 1 calcification. Spine calcifications were depicted in 80.5%, 27.3%, and 35.1% at the anterior, intracanal and posterior segments respectively. Calcifications were mainly localized on thoracic spine. Inter reader reliabilities were good for hands and moderate for spine respectively. Spine calcifications and periarticular calcifications in the hands were associated (P = .012). Calcinosis in the hands was related to PAH (P = .02). Posterior calcification segment and foraminal calcifications were associated with interstitial lung disease (ILD) (P = .029) and death (P = .001).More than 80% of systemic sclerosis patients presented spine calcifications. A significant association between hands and spinal calcifications were confirmed and some localization in the posterior segment considered as a bad prognostic factor.

Low Back Pain and Sacroiliitis on Cross-Sectional Abdominal Imaging for Axial Spondyloarthritis Diagnosis in Inflammatory Bowel Diseases.

BACKGROUND: Joint damage is the most frequent extraintestinal manifestation in inflammatory bowel disease (IBD). AIMS: The aim of the study was to assess the value of low back pain (LBP) associated with sacroiliitis on abdominal imaging for the diagnosis of spondyloarthritis (SpA) in IBD. METHODS: We used a questionnaire assessing rheumatological symptoms for all patients with abdominal computed tomography (CT) and magnetic resonance enterography (MRE). Sacroiliitis was assessed on available CT and MRE. Patients were classified as axial SpA according to the Assessment of SpondyloArthritis International Society criteria. RESULTS: Fifty-one patients completed the questionnaire and performed both exams. LBP was present in 27 patients (52.9%), and 10 (19.6%) had an inflammatory component. Sacroiliitis was reported in 12 patients (23.5%), and 6 of them suffered from LBP. Among the 20 patients referred to the rheumatologist, 11 patients suffered from LBP. One patient was HLA-B27 positive and presented sacroiliitis. For the last 10 patients, none of them had a sacroiliitis, and 2 patients were negative for HLA-B27. CONCLUSION: An axial SpA has been diagnosed in 11.8% of IBD patients undergoing cross-sectional imaging, whereas one-fifth had inflammatory LBP, and sacroiliitis was observed in one-quarter of them. To optimize the diagnosis of axial SpA, HLA-B27 testing might be required for patients with both IBD and LBP, but this will require further investigation before its implementation in routine practice.

Spa therapy with physical rehabilitation is an alternative to usual spa therapy protocol in symptomatic knee osteoarthritis.

The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.