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Background Acute lumbosacral radiculopathy from disc herniation is common and particularly painful. The challenge is to provide sufficient relief to patients until the natural regression of the herniated disc allows them to heal, primarily using conservative medical treatment combining physical measures, antinociceptive analgesics, and systemic anti-inflammatory drugs. Nerve root impingement is likely to cause acute neuropathic pain, which is not currently managed by standard conservative medical treatment. We hypothesised that a short course of gabapentin could improve pain management in acute lumbosacral radiculopathy from disc herniation. Methods The GRADE (Gabapentin versus placebo for the treatment of acute lumbosacral RAdicular pain caused by Disc hErniation) study is a prospective, randomized, multicenter, double-blind, superiority phase III trial comparing a 3-day regimen of gabapentin to placebo with a 1:1 ratio. Patients with acute lumbosacral radiculopathy from disc herniation with symptoms of less than 3 months are included in 6 centres in France. The primary outcome is the change in the radicular pain Visual Analogue Scale between Day 1 and Day 4. Intention-to-treat analysis will be applied primarily. Discussion Ethics approval was obtained from the committee for the protection of persons (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 1: 1-21-023 ID 11548). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the pain management in acute lomboradicular pain. Trial registration number EudraCT: 2020-002849-42 Clinicaltrials NCT04865042. 19 April 2021.

The objectives of our study were to assess retention rate, safety, and predictive factors for retention of subcutaneous (SC) TNF inhibitors (TNFi) (adalimumab (ADA), etanercept (ETN), golimumab (GOL), and certolizumab pegol (CZP)) in axial spondyloarthritis (axSpA) depending on the line of treatment in real-life conditions. A multicentre retrospective observational study was conducted including 552 patients fulfilling the ASAS criteria for axSpA followed in the RIC-France register who began SC-TNFi between 01/01/13 and 08/31/2018 for a total of 824 prescriptions. Taking all lines of treatment into account, GOL had a significantly higher retention rate compared with ADA, ETN, and CZP with a mean retention length of 59 months. As first-line bDMARDs, GOL had a significantly higher retention rate compared with ADA and ETN. ETN had the best retention rate when prescribed as at least 3rd bDMARD. Taking all lines of treatment into account, female sex, peripheral disease, BASDAI at initiation, and line of treatment were predictive factors for treatment cessation. Primary inefficiency was the most frequent reason for treatment cessation. In conclusion, GOL showed the highest retention rate in axSpA. Male sex, absence of peripheral disease, and early line of prescription were associated with better SC-TNFi retention in axSpA.

ObjectivesPrevious studies demonstrated equivalence in terms of efficacy and safety of biosimilars (bsDMARDs) compared to original treatments (boDMARDs) and in switching situations. Less is known about what happens when initiating a bsDMARD in a molecule naïve patient. The objectives of our study were to compare the retention of treatment of subcutaneous boDMARDs and bsDMARDs globally, depending on the disease [rheumatoid arthritis (RA), spondyloarthritis (SpA), or psoriatic arthritis (PsA)], molecule [etanercept (ETN) or adalimumab (ADA)], line of treatment, or presence of citrate in the context of first use of each molecule (namely initiation) and to analyze treatment retention’s predictive factors.Materials and methodsThis multicenter retrospective study used data from shared medical records of the RIC-FRANCE network, encompassing the prescription of hospital rheumatologists and attached practitioners, of patients with RA, SpA, or PsA, with the starting ETN between 03/10/2016 and 31/07/2020, or ADA between 23/10/2018 and 31/07/2020. Clinical data were collected from medical records. Retention analysis was performed using Kaplan–Meier curves and the log-rank test. Retention’s predictive factors were analyzed using Cox proportional-hazard ratio.ResultsEight hundred forty-five prescriptions were analyzed: 340 boDMARDs and 505 bsDMARDs. About 57% of prescriptions concerned women. The mean age was 51.8 years. About 38% were prescriptions for RA, 16% for PsA, and 46% for SpA. An increase in the initiation over time was observed for both ETN and ADA. The retention rate of bsDMARDs was superior to boDMARDs’ one (39 vs. 23 months; p = 0.045). When molecules are compared, the difference was significant only for ETN (45 vs. 19 months for boDMARD; p = 0.0265). When comparing diseases, the difference in favor of bsDMARDs was significant in patients with RA only ( p = 0.041). Citrated treatments displayed better retention compared to citrate-free treatments ( p = 0.0137). Multivariable analysis of predictive factors for the cessation of treatment found shorter disease duration, boDMARD prescription, hospital practitioner prescription, late line of treatment, and female sex as significant. More side effects were observed with boDMARDs, especially more infections (17.8% vs. 7.8%).ConclusionEven if bsDMARDs’ prescription increases over time, its penetration rate is still below expectations. bsDMARDs displayed better retention compared to boDMARDs, especially for ETN, and in patients with RA. Citrated treatments had better retention. Prescription by a full-time hospital-based rheumatologist is associated with poorer retention.

ObjectiveTo describe the prevalence of fibromyalgia (FM) in an axial spondyloarthritis (axSpA) population and to confirm that concomitant FM had a negative impact on tumour necrosis factor blockers’ (TNFb) response.DesignProspective observational study with two visits 3 months apart.PatientsAdult patients with AxSpa initiating a TNFb.Study groupsFM was defined by the Fibromyalgia Rapid Screening Tool (FiRST) at baseline and also by a sustained positive FiRST (both visits) and by a fulfilment of the 1990 American College of Rheumatology criteria for FM.Statistical analysisPrevalence of FM; evaluation of the impact of a concomitant FM on TNFb response (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) as primary endpoint), adjusted by factors known to have an impact on TNFb response.ResultsAmong the 508 patients included in the main analysis, 192 (37.8%) were screened at baseline as FM. Percentage of success after 12 weeks of treatment was lower in the FM group for most of the effectiveness endpoints (eg, BASDAI 50: 45.3% vs 54.1% in the FM/not FM groups according to the FiRST), except for the C reactive protein change endpoints which were not different across groups.ConclusionThis study confirms that FM coexists in patients with axSpA and that its presence seems to have a negative impact on TNFb response, which seems more related to the self-reported instruments used in its evaluation, rather than a different treatment effect of the molecule in this subgroup of patients.

To develop and validate a questionnaire assessing patient knowledge in rheumatoid arthritis (RA). Knowledge considered essential for patients with RA was identified through a series of Delphi rounds among rheumatologists, health professionals (HPs), patients, and then reformulated to construct the knowledge questionnaire. Cross-sectional multicenter validation was performed in 12 rheumatology departments to assess internal validity (Kuder–Richardson coefficient), external validity, acceptability, reproducibility (Lin’s concordance correlation coefficient) and sensitivity to change (difference in total score before and after patient education sessions). Associations between patient variables and knowledge levels were evaluated. RAKE (RA Knowledge questionnairE) is a self-administered 45-item questionnaire scored 0–100, with a 32-item short-form survey assessing knowledge of disease, comorbidity, pharmacological treatments, non-pharmacological treatments, self-care and adaptative skills. Of 130 patients included in the validation study, 108 were women. Acceptability was good with < 5% missing data. Internal validity coefficient was 0.90. Mean (standard deviation) long-form score was 72.8 ± 17.8, with lower scores in comorbidity and self-care and higher scores in adaptive skills. Reproducibility was good (0.86 [0.80; 0.92]). RAKE score was positively correlated with the patients’ level of education and the HPs’ opinion on the patients’ knowledge. RAKE score showed good sensitivity to change: 66.8 ± 16.4 then 83.8 ± 12.7, representing a hedges effect size of 1.14 [95% CI 0.73; 1.55]. RAKE is an updated questionnaire assessing essential knowledge for patients with RA to enhance self-management according to current guidelines and the patients’ perspective. RAKE can usefully inform patient education interventions, routine care and research.

Objectives: Data on abatacept (ABA) persistence in routine practice are limited. We aimed to study ABA persistence rates at 12 months, according to the date of initiation, and to analyze the factors associated with persistence at 12 months. Methods: We performed an observational, ambispective, multi-center study from January 2008 to July 2016, based on the French-RIC Network. We defined three groups of patients followed up for rheumatoid arthritis (RA), according to the date of initiation of ABA therapy: Group 1 (from 2007 to 31 July 2010: ABA indicated after anti-TNF failure); Group 2 (from 1 August 2010 to 31 March 2014: ABA indicated after conventional antirheumatic drugs failure); Group 3 (from 1 April 2014 to 1 July 2016: ABA available by the subcutaneous injection). Results: Among 517 patients who initiated ABA, drug persistence at 12 months was 68%. The only factor significantly associated with persistence rate at 12 months was C-reactive protein (CRP) < 10 mg/L at ABA initiation (odds ratio (OR) 0.6, 95% confidence interval 0.3–0.9; p = 0.0016). There was no significant difference in drug persistence according to date of initiation, the line of biological disease-modifying antirheumatic drugs (bDMARD) therapy or the route of administration. Conclusions: In routine practice, over time, ABA has come to be initiated earlier in the course of therapy for RA in France. Abatacept persistence is similar to that reported in the Orencia Rheumatoid Arthritis (ORA) registry, and does not differ according to the date of initiation. The only factor found to be associated with the persistence rate at 12 months was CRP < 10 mg/L at ABA initiation.

OBJECTIVE--To assess the usefulness of high resolution computed tomography (HRCT) of the lungs in patients with rheumatoid arthritis (RA) with and without respiratory symptoms. PATIENTS AND METHODS--Eighty eight RA patients with a mean duration of disease 12 (SD 8) years were evaluated. Eleven patients were excluded because of previous exposure to silica. The 77 remaining patients formed two groups according to the absence (group I, n = 38) or the presence (group II, n = 39) of chronic respiratory symptoms. A control group consisted of 51 non-smoking, healthy patients. RESULTS--The most frequent abnormalities observed in the 77 RA patients were bronchiectasis or bronchiolectasis (n = 23, 30%), pulmonary nodules (n = 17, 22%), subpleural micronodules or pseudoplaques (n = 13, 17%), ground glass opacities (n = 11, 14%), and honeycombing (n = 8, 10%). Bronchiectasis or bronchiolectasis (p = 0.012), rounded opacities (p = 0.016), ground glass attenuation (p = 0.004), and honeycombing (p = 0.002) were found more often in RA group II (with respiratory symptoms) than in group I (no respiratory symptoms). Non-linear septal opacities were more frequent in group I than in the control group, but other HRCT findings did not differ statistically significantly between group I and the control group. CONCLUSION--Bronchiectasis may be a characteristic lung change in RA patients. Abnormalities on HRCT are less frequently observed in the absence of respiratory symptoms than in the presence of such symptoms (29% versus 69%).