Standardized reporting for systematic global evaluation of axial spondyloarthritis: An evidence-based and consensus-driven initiative.

INTRODUCTION: National and international scientific societies advocate for a regular, systematic, and standardized global evaluation of axial spondyloarthritis (axSpA) patients. However, there are no recommendations specifying the content of this global evaluation. This initiative aimed to propose a standardized reporting framework, using evidence-based and consensus approaches, to collect data on all domains of axSpA. METHODS: A literature review and consensus process involved a steering committee and an expert panel of 37 rheumatologists and health professionals. The first steering committee took place in March 2022 and identified the main domains for inclusion in the standardized report. A hierarchical literature review was conducted to identify items within these domains and tools for assessment. The items and tools for assessment were discussed and consensus was reached through a vote session during an expert meeting that took place in March 2023. RESULTS: The steering committee identified four main domains to include in the standardized reporting framework: disease assessment, comorbidities, lifestyle, and quality of life. Items and tools for assessment were adopted after the expert meeting. Additionally, recommendations regarding digital tools (websites, apps, social media) were provided. CONCLUSION: This initiative led to a consensus, based on evidence and expertise, on a reporting framework for use during periodic systematic global evaluations of axSpa in daily practice.

Musculoskeletal corticosteroid injections: Recommendations of the French Society for Rheumatology (SFR).

Musculoskeletal corticosteroid injections are widely performed, although the exact practice varies greatly due to advances in knowledge and techniques. This justifies updating and drawing up good practice recommendations. Using a consensus model formalized by the French National Authority for Health (HAS) and based on a literature review that resulted in a "white book", 13 recommendations were developed by a group of experts. These recommendations were then sent online to 48 specialists for evaluation, 27 of whom were rheumatologists and 15 of whom were general practitioners. These recommendations were also presented at the 34th annual meeting of the French Society for Rheumatology (SFR) (Paris, December 2021) at a symposium attended by a hundred or so rheumatologists, who voted on these recommendations in person. The results are presented as an overall score out of 10, a median out of 10 and as tertiles. The agreement was excellent for 10 of these 13 recommendations, with mean values of 8.5 to 9.1 out of 10, median values of 9 or 10 out of 10 and agreement of 91.7% to 97.9%, which corresponds to a consensus. The 3 other recommendations were broadly supported but were the subject of more debate. One relates to patient information (mean 7.3/10, median 8/10, upper tertile 72.9%) with discussion about the waiting period. Another related to the summary report (mean 8.4/10, median 9, upper tertile 91.7%) with discussions about its content and the need to specify the lot number of the injected product. The last one related to periprosthetic injections and the need to consult and get approval from a specialist (mean 8.0/10, median 8, upper tertile 83.3%) with mostly the general practitioners having reservations. In all, there is a very strong consensus among the musculoskeletal corticosteroid injection experts and specialists consulted, which justifies them being taken into consideration to improve our daily practice.

Elicitation of Rheumatologist Preferences for the Treatment of Patients with Rheumatoid Arthritis After the Failure of a First Conventional Synthetic Disease-Modifying Anti-Rheumatic Agent.

INTRODUCTION: Rheumatoid arthritis (RA) clinical guidelines do not provide strong recommendations for the choice of disease-modifying anti-rheumatic drugs (DMARD) in patients with an inadequate response to methotrexate (MTX), and only limited evidence is available on factors influencing rheumatologist treatment decisions. We aimed to describe therapeutic preferences after the failure of a first-line strategy of MTX in simulated cases of patients with RA. METHODS: Fictional but realistic case-vignettes (n = 64) of patients with RA and an inadequate response to MTX were developed with a combination of RA-poor prognostic factors and comorbidities. Physicians were presented with eight vignettes and chose the most and least appropriate therapeutic option from the following six options randomly proposed 3 by 3: (1) replacing MTX with another csDMARD; (2) combining MTX with one or more csDMARDs; (3) adding a bDMARD of either TNF inhibitors (TNFi), tocilizumab (TCZ), abatacept (ABA), or rituximab (RTZ). A total of 1605 complete case vignettes were produced and randomly assigned to a representative sample of French rheumatologists. For each vignette, whenever a treatment was preferred, one point was incremented for this treatment; if this treatment was the least desired, one point was removed. Preferences were elicited using a normalized best-worst score. RESULTS: Two hundred and four French rheumatologists participated in the study with each vignette being assessed 20-28 times for a completion rate of 94%. TNFi was the first-choice strategy (80% of vignettes), except in cases with a history of infection and pulmonary comorbidity, where ABA was the first preference (85%). TCZ came third in 83% of the cases. Other options were never preferred and repeatedly yielded negative scores. CONCLUSIONS: We observed a conservative trend with TNFi as the main therapeutic choice for patients with RA and inadequate response to MTX. Preference for bDMARD-based strategies increased with the number of RA-poor prognosis factors, whereas an increase in the number of comorbidities resulted in an increased preference for ABA. Understanding clinical decision-making will be particularly important as the therapeutic landscape for RA continues to evolve.

Benefits of Switch from Oral to Subcutaneous Route on Adherence to Methotrexate in Patients with Rheumatoid Arthritis in Real Life Setting.

PURPOSE: The purpose of the APRIM study (for Adherence Polyarthrite Rhumatoïde Injection Methotrexate) was to investigate the change in treatment adherence of patients with rheumatic arthritis (RA) who switched from oral to subcutaneous methotrexate (MTX). PATIENTS AND METHODS: Prospective, observational study in RA patients treated with MTX and switching from oral to subcutaneous (SC) route in real-life conditions. Data on motivations for switch, disease activity (DAS28-CRP), quality of life (AISM-2 SF), disability (HAQ-DI), and adherence to MTX were collected at inclusion (M0) and 6 months later (M6). Adherence was assessed by the 8-item Morisky Medication Adherence Scale (MMAS-8) and defined as high (MMAS-8 = 8), medium (MMAS-8 = 6 or ≤8) or low (MMAS-8 < 6). The primary evaluation criterion was the proportion of patients who maintained strong adherence or improved adherence by at least one category (from low to medium or strong or from medium to strong) between M0 and M6. RESULTS: The analysis involved 207 patients (age 60.4±12.7 years, 75.2% females). 6.7% were in remission and 15.5% had low disease activity (LDA) at baseline. 58.5% reached the primary criterion and strong adherence rate increased from 42.0% to 50.7%. Change of route was combined with increased MTX dose in 34.8% of patients. Switch to SC route increased the proportion of patients with remission or LDA from 22.8% to 52.9% and increased quality of life even in patients with unchanged MTX dose. CONCLUSION: Overall, change from oral to SC route improved adherence to MTX, RA control and quality of life independently of change in MTX dose.

Cut-off value to identify a flare using the Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire: analysis of the TOSCA study.

OBJECTIVE: The Flare Assessment in RA (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between two consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare. METHODS: The Tocilizumab SubCutAneous study evaluated the efficacy and safety of s.c. tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12 and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve. RESULTS: A total of 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: ρ = 0.41 at W12 (P < 0.0001) and 0.51 at W24 (P < 0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81. CONCLUSION: FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.

Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis.

OBJECTIVES: To establish recommendations for pharmacological treatment of knee osteoarthritis specific to France. METHODS: On behalf of the French Society of Rheumatology (SFR), a bibliography group analyzed the literature on the efficacy and safety of each pharmacological treatment for knee osteoarthritis. This group joined a multidisciplinary working group to draw up recommendations. Strength of recommendation and quality of evidence level were assigned to each recommendation. A review committee gave its level of agreement. RESULTS: Five general principles were established: 1) need to combine pharmacological and non-pharmacological treatments, 2) personalization of treatment, 3) symptomatic and/or functional aim of pharmacological treatments, 4) need to regularly re-assess the treatments and 5) discussion about arthroplasty if medical treatment fails. Six recommendations involved oral treatments: 1) paracetamol should not necessarily be prescribed systematically and/or continuously, 2) NSAIDs, possibly as first-line, 3) weak opioids, 4) strong opioids, 5) symptomatic slow-acting drugs of osteoarthritis, and 6) duloxetine (off-label use). Two recommendations involved topical agents (NSAIDs and capsaicin<1%). Three recommendations involved intra-articular treatments: corticosteroid or hyaluronic acid injections that can be proposed to patients. The experts did not draw a conclusion about the benefits of platelet-rich plasma injections. CONCLUSION: These are the first recommendations of the SFR on the pharmacological treatment of knee osteoarthritis.

Data to be collected for an optimal management of axial spondyloarthritis in daily practice: Proposal from evidence-based and consensual approaches.

OBJECTIVE: To propose a list of variables to be collected right after the diagnosis has been made and during the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice. METHODS: The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of ax-SpA by means of a systematic literature research; (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of each variable in a 4 grade scale from "not very useful/useless" to "mandatory"; (3) a consensus on the minimum interval of time for periodic assessment of the selected variables on a 5 grade scale from "at each visit" to "never to be re-collected". RESULTS: The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Data to be collected at the initial systematic review comprised 5 patient's self-administered questionnaires, 3 variables of the physician's interview, 2 variables of the physical examination, 2 variables of the specific ax-SpA imaging and 2 other investigations. Two variables were recommended to be systematically collected at each visit, 1 variable twice a year, 6 variables yearly and 1 variable every 2 years. CONCLUSIONS: Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported right after the diagnosis and during follow-up of patients with ax-SpA in daily practice.

Recommendations for the assessment and optimization of adherence to disease-modifying drugs in chronic inflammatory rheumatic diseases: A process based on literature reviews and expert consensus.

BACKGROUND: Adherence to treatment is a key issue in chronic inflammatory rheumatic diseases (CIRDs). OBJECTIVE: To develop recommendations to facilitate in daily practice, the management of non-adherence to disease-modifying drugs in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, connective tissue diseases or other CIRDs. METHODS: The process comprised (a) systematic literature reviews of methods (including questionnaires) to measure non-adherence, risk factors for non-adherence and efficacy of targeted interventions; (b) development of recommendations through consensus of 104 rheumatologist and nurse experts; (c) assessment of agreement and ease of applicability (1-5 where 5 is highest) by the 104 experts. RESULTS: (a) Overall, 274 publications were analysed. (b) The consensus process led to 5 overarching principles and 10 recommendations regarding adherence. Key points include that adherence should be assessed at each outpatient visit, at least using an open question; questionnaires and hydroxychloroquine blood level assessments may also be useful. Risk factors associated to non-adherence were listed. Patient information and education, and patient/physician shared decision, are key to optimize adherence. Other techniques such as formalized education sessions, motivational interviewing and cognitive behavioral therapy may be useful. All health professionals can get involved and e-health may be a support. (c) The agreement with the recommendations was high (range of means, 3.9-4.5) but ease of applicability was lower (2.7-4.4). CONCLUSIONS: Using an evidence-based approach followed by expert consensus, this initiative should improve the assessment and optimization of adherence in chronic inflammatory rheumatic disorders.

Methods to improve medication adherence in patients with chronic inflammatory rheumatic diseases: a systematic literature review.

OBJECTIVE: Lack of adherence to treatment is frequent in chronic inflammatory rheumatic diseases and is associated with poorer outcomes. The objective of this study was to describe and evaluate interventions that have been proposed to enhance medication adherence in these conditions. METHODS: A systematic literature review was performed in Pubmed, Cochrane, Embase and clinicaltrials.gov databases completed by the rheumatology meeting (ACR, EULAR and SFR) abstracts from last 2 years. All studies in English or French evaluating an intervention to improve medication adherence in chronic inflammatory rheumatic diseases (rheumatoid arthritis (RA), spondyloarthritis (SpA), crystal related diseases, connective tissue diseases, vasculitis and Still's disease) were included. Interventions on adherence were collected and classified in five modalities (educational, behavioural, cognitive behavioural, multicomponent interventions or others). RESULTS: 1325 abstracts were identified and 22 studies were finally included (18 studies in RA (72%), 4 studies in systemic lupus erythematosus (16%), 2 studies in SpA (8%) and 1 study in gout (4%)). On 13 randomised controlled trials (RCT) (1535 patients), only 5 were positive (774 patients). Educational interventions were the most represented and had the highest level of evidence: 8/13 RCT (62%, 1017 patients) and 4/8 were positive (50%). In these studies, each patient was individually informed or educated by different actors (physicians, pharmacists, nurses and so on). Supports and contents of these educational interventions were heterogenous. CONCLUSION: Despite the importance of medication adherence in chronic inflammatory rheumatic disorders, evidence on interventions to improve medication adherence is scarce.

Collection and management of selected comorbidities and their risk factors in chronic inflammatory rheumatic diseases in daily practice in France.

INTRODUCTION: In chronic inflammatory rheumatic diseases (CIRDs), comorbidities such as cardiovascular disease and infections are sub-optimally managed. EULAR recently developed points to consider to collect and report comorbidities. The objective of this present study was to develop a pragmatic guide to collect, report and propose management recommendations for comorbidities, from a rheumatologist perspective. METHODS: The collection and reporting of comorbidities and risk factors was adapted from the EULAR points to consider. To develop management recommendations, the process comprised (1) systematic literature reviews by 3 fellows and (2) a 2-day consensus process involving 110 experts (rheumatologists and health professionals). Votes of agreement (Likert 1-5 where 5 indicates full agreement) were obtained. RESULTS: The six selected comorbidities were ischemic cardiovascular diseases, malignancies, infections, diverticulitis, osteoporosis and depression. The literature review retrieved 97 articles or websites, mostly developed for the general population. The consensus process led to reporting presence of comorbidities, current treatment, risk factors (e.g. hypertension), screening (e.g. mammography) and prevention (e.g. vaccination). Management recommendations include physical examination (e.g. blood pressure or lymph node examination), prescribing screening procedures, and interpreting results to refer in a timely manner to appropriate other health professionals. Agreement was high (mean±standard deviation, 4.37±0.33). CONCLUSIONS: Using an evidence-based approach followed by expert consensus, this initiative furthers the dissemination in France of the EULAR points to consider, and clearly defines what part of the management of comorbidities is potentially within the remit of rheumatologists. This initiative should facilitate systematic management of patients with CIRDs.