Canakinumab treatment real world evidence in 3 monogenic periodic fever syndromes in 2009-2022: an interim analysis using the French JIR cohort database.

BACKGROUND: Our study aimed to provide real-world evidence on the treatment patterns, effectiveness and safety of canakinumab in France in Familial Mediterranean Fever (FMF), Mevalonate Kinase Deficiency (MKD), and Tumor necrosis factor Receptor Associated Periodic Syndrome (TRAPS). METHODS: This study used the JIR cohort, a multicentre international registry created in 2013 to collect data on patients with juvenile inflammatory rheumatic diseases. French patients diagnosed with FMF, MKD or TRAPS and treated with canakinumab were included in this study. RESULTS: 31 FMF, 26 MKD and 7 TRAPS patients received canakinumab during the study period. Most of them initiated canakinumab at the recommended dose of 2 mg/kg or 150 mg, but less than half of FMF and MKD patients initiated it at the recommended frequency (every 4 weeks). Two years after initiation, the rate of patients still on treatment was 78.1% in FMF, 73.7% in MKD, and 85.7% in TRAPS patients. While the dose per injection remained globally the same over the course of the treatment, some adjustments of the dose intervals were observed. Six patients had a severe adverse event reported. Of those, three were possibly related to canakinumab. CONCLUSION: This interim analysis showed a good maintenance of canakinumab treatment 2 years after initiation and confirmed its safety profile in real-life practice in France in patients diagnosed with FMF, MKD and TRAPS. The high variety of dose and interval combinations observed in canakinumab treated patients let suppose that physicians adapt the posology to individual situations rather than a fixed treatment plan.

Riociguat real-world use in patients with chronic thromboembolic pulmonary hypertension: A retrospective, observational cohort study in France.

BACKGROUND: Riociguat is the first approved treatment for inoperable and persistent/recurrent post-surgery chronic thromboembolic pulmonary hypertension (CTEPH). The RetrospectIve Adempas® stuDy (RiAD) aimed to describe the real-world utilization of riociguat in France. METHODS: In this retrospective multicentric study in patients initiating riociguat, dosing regimen, co-treatments and clinical characteristics were collected over a 2-year follow-up period. RESULTS: A total of 173 patients (mean age, 71.4 years; female, 63.0%; NYHA II-III, 80.3%) were included from January 2015 to December 2016 in 18 centers. All patients were diagnosed with CTEPH (75.7% inoperable and 20.8% with persistent/recurrent pulmonary hypertension [pH] after surgery) with mean (SD) right atrial pressure 7.6 (4.2) mmHg, mean pulmonary artery pressure 43.0 (11.4) mmHg and mean cardiac output 4.1 (1.1) L/min. Before riociguat initiation, 32.4% of patients previously received at least one pH-specific therapy. At initiation, 93.1% of patients were receiving anticoagulants and 83.2% were not receiving pH-specific co-treatments. Riociguat was initiated at 1 mg three times daily (t.i.d.) in 85.5% of patients and 82.1% were receiving 2.5 mg dose t.i.d. at 24 months. The maximal daily dose of 7.5 mg was never exceeded. At 24 months, the estimated rate of patients still taking riociguat was 78.8% with an estimated mean (SD) time on treatment of 20.1 (0.5) months per patient. No new safety signals were recorded. CONCLUSIONS: The results of this real-world study show that riociguat is used in France in accordance with its therapeutic indication in patients with inoperable or persistent/recurrent post-operative CTEPH and confirm its long-term safety.

Mental health condition of college students compared to non-students during COVID-19 lockdown: the CONFINS study.

OBJECTIVES: To estimate the effect of student status on mental health condition during COVID-19 general lockdown in France. DESIGN: Cross-sectional analysis comparing students and non-students recruited in the same study. SETTING: Participants of the web-based CONFINS study implemented during the general lockdown in France in spring 2020. PARTICIPANTS: 2260 participants (78% women) including 1335 students (59%). PRIMARY AND SECONDARY OUTCOME MEASURES: Through an online questionnaire, participants declared if they have experienced suicidal thoughts, coded their perceived stress on a 10-points scale and completed validated mental health scales (Patient Health Questionnaire-9 for depressive symptoms, Generalised Anxiety Disorder-7 for anxiety symptoms) during the last 7 days. The effect of college student status on each mental health condition was estimated using multivariate logistic regression analyses. Stratified models for students and non-students were performed to identify population-specific factors. RESULTS: Student status was associated with a higher frequency of depressive symptoms (adjusted OR (aOR)=1.58; 95% CI 1.17 to 2.14), anxiety symptoms (aOR=1.51; 95% CI 1.10 to 2.07), perceived stress (n=1919, aOR=1.70, 95% CI 1.26 to 2.29) and suicidal thoughts (n=1919, aOR=1.57, 95% CI 0.97 to 2.53). Lockdown conditions that could be potentially aggravating on mental health like isolation had a higher impact on students than on non-students. CONCLUSIONS: College students were at higher risk of mental health disturbances during lockdown than non-students, even after taking into account several potential confounding factors. A close follow-up and monitoring of students' mental health status is warranted during lockdown periods in this vulnerable population.

OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?

INTRODUCTION: Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives. METHODS: Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores). RESULTS: One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period. CONCLUSION: Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.

Compliance with national guidelines for antibiotic prophylaxis prescription with a surgical abortion: Results of the Mya study.

PURPOSE: Performing an antibiotic prophylaxis (ATBP) with a surgical abortion (SA) is recommended in numerous countries, including France where the CNGOF has issued guidelines. There is little data regarding the actual application of these guidelines in clinical practice. The aim of this study was to evaluate the practice of ATBP with SA and to assess the degree of compliance with the national guidelines. METHODS: This longitudinal, prospective, multicenter, non-interventional study was undertaken between December 2013 and July 2014 with the objective of assessing the modalities of prescription of ATBP under real-life conditions in the setting of SA, and to compare it with the national guidelines. RESULTS: A total of 542 pregnant patients agreed to participate and were included by 36 French hospitals. Of these 36 active centers, 18 (50%) systematically prescribed an ATBP, while 10 (27.8%) prescribed an ATBP depending on the risks for the patient. Of these 542 patients, 263 (48.5%) received an ATBP prescription, 274 (50.6%) did not receive such a prescription. The prescribed ATBP was metronidazole (88/263 (33.5%)), azythromycin (76/263 (28.9%)), or doxycycline (44/263 (16.7%)). In total, 208/263 (79.1%) of the patients received an ATBP. Finally, three factors were identified as independent contributors that influence the prescription of an ATBP: the prescribed cervix preparation, the type of center, and the number of surgical abortions per year in the center over 500/year. CONCLUSION: Only half of the patients who undergo an SA receive a prescription for ATBP. Of the prescribed antibiotics, 80% correspond with the recommended ones.

Defining the "Frequent Exacerbator" Phenotype in COPD: A Hypothesis-Free Approach.

BACKGROUND: The COPD "frequent exacerbator" phenotype is usually defined by at least two treated exacerbations per year and is associated with a huge impact on patient health. However, existence of this phenotype and corresponding thresholds still need to be formally confirmed by statistical methods analyzing exacerbation profiles with no specific a priori hypothesis. The aim of this study was to confirm the existence of the frequent exacerbator phenotype with an innovative unbiased statistical analysis of prospectively recorded exacerbations. METHODS: Data from patients with COPD from the French cohort in Exacerbations of COPD Patients (EXACO) were analyzed using the KmL method designed to cluster longitudinal data and receiver operating characteristic (ROC) curve analysis to determine the best threshold to allocate patients to identified clusters. Univariate and multivariate analyses were performed to study characteristics associated with different clusters. RESULTS: Two clusters of patients were identified based on exacerbation frequency over time, with 2.89 exacerbations per year on average in the first cluster (n = 348) and 0.71 on average in the second cluster (n = 116). The best threshold to distinguish these clusters was two moderate to severe exacerbations per year. Frequent exacerbators had more airflow limitation, symptoms, and health-related quality of life impairment. A simple clinical score was derived to help identify patients at risk of exacerbations. CONCLUSIONS: These analyses confirmed the existence and clinical relevance of a frequent exacerbator subgroup of patients with COPD and the currently used threshold to define this phenotype.