Translational research in immune and inflammatory diseases; what are the challenges, expected advances, and innovative therapies?

Despite very different aetiologies and clinical expressions, advancing knowledge in the physiopathology and treatment of immune and inflammatory diseases (IID) prompts us to consider them as a whole. These are chronic, often incapacitating and painful illnesses that progress and destroy organs. Management by discipline too often leads to erroneous diagnoses and sometimes inappropriate treatment. More integrated translational research would further understanding of the complex relationships between cytokines and organ damage, which vary with the conditions and patients, making it possible to develop new biomarkers and personalize treatment. The research in France has very many strengths but its organization is fragmented. Better coordinated research into IID, which could be based on creating a strategic valorization field (domaine de valorisation stratégique, DVS) and thematic multi-organization institute (Institut thématique multi-organismes ITMO), would advance patient management.

Treatment persistence and changes in fracture risk, back pain, and quality of life amongst patients treated with teriparatide in routine clinical care in France: results from the European Forsteo Observational Study.

OBJECTIVES: The European Forsteo Observational Study assessed the clinical fracture incidence, back pain, quality of life (QoL), and treatment persistence amongst post-menopausal women, who were prescribed teriparatide in routine care in eight European countries. We present the results for France, with health-insurance reimbursement criteria channel teriparatide to women with severe disease and limit treatment to 18 months. METHODS: A representative sample of women initiating teriparatide in France was followed in routine care for 36 months. We described patients' characteristics at baseline and persistence to teriparatide (Kaplan-Meier analysis), fracture incidence, back pain, and QoL (EQ-5D) at baseline, 18 and 36 months follow-up (last-observation-carried-forward (LOCF) and mixed-models-for-repeated-measures (MMRM). RESULTS: One hundred and sixteen rheumatologists included 309 patients, of whom 290 (93.9%) had at least one follow-up visit. Women's mean age (standard deviation) was 74.5 years (7.4) and 296 (95.8%) had greater or equal to two vertebral fractures prior to teriparatide initiation. Clinical fracture incidence, mainly vertebral fractures, decreased around 6 months after teriparatide initiation, and was sustained at 36 months (P=0.013) when most patients were treated by anti-resorptives. Back pain and EQ-5D measures improved significantly at 18 and 36 months (P<0.0001) in the LOCF analyses but did not improve in the EQ-5D VAS measure after covariate adjustment in the MMRM model. Median treatment duration was 17.4 months. CONCLUSION: French women initiating teriparatide in routine care had severe osteoporosis and showed good treatment persistence, consistent with France's insurance reimbursement criteria. Improvements in fracture risk and back pain began soon after treatment and was maintained at 36 months follow-up.

Prescribing patterns of duloxetine in France: a prescription assessment study in real-world conditions.

Duloxetine is a serotonin and norepinephrine reuptake inhibitor approved in the European Union for the treatment of major depressive disorder, generalized anxiety disorder, and diabetic peripheral neuropathic pain in adults. This study aimed to assess the real-world conditions of duloxetine use in France. Between April 2009 and January 2010, 290 dispensing pharmacies, randomly selected from a nationally representative list, included 1,104 patients who presented a duloxetine prescription and consented to the study. Demographic, clinical, and prescription data were extracted from pharmacy records and requested from prescribing physicians. Of the 294 patients with full data available, the mean age (standard deviation) was 54.5 (13.5) years; 74.1% were female; and 86.7% presented with a renewal prescription. 73.5% of patients had major depressive disorder; 3.4% generalized anxiety disorder; and 3.4% diabetic peripheral neuropathic pain. Overall, 78.2% (95% CI: 73.1; 82.8) of patients received duloxetine for an EU-approved indication; 95.2% (95% CI: 92.1; 97.4) of patients had no contra-indication to duloxetine; and 99.0% (95% CI: 97.0; 99.8) received an approved dose. Combining these three criteria, the overall approved use of duloxetine was 73.7% (95% CI: 68.3; 78.7). The strengths and limitations of the study design are discussed.

Effectiveness of two formulations of oral olanzapine in patients with schizophrenia or bipolar disorder in a natural setting: results from a 1-year European observational study.

OBJECTIVE: This study aims to assess the proportion of patients with schizophrenia or bipolar disorder who discontinued treatment with one of two oral formulations of olanzapine within 12 months in outpatient settings in Germany, Greece, and France. METHODS: This 1-year, prospective, observational study included patients who had recently initiated treatment with olanzapine-coated tablets (OC) or the orodispersible (OD) formulation. Primary endpoint was olanzapine discontinuation for any reason. Clinical and functional status were also evaluated. RESULTS: Out of 927 enrolled patients, 903 were included in the analyses (612 patients with schizophrenia, 291 with bipolar disorder). Within 12 months, 46 of 903 patients discontinued olanzapine. Most (95%) patients remained on olanzapine for 12 months with similar rates for patients with either diagnosis (94.5% for schizophrenia, 94.9% for bipolar disorder) and for both formulations (93.7% with OC, 95.3% with OD). The only factor significantly associated with time to discontinuation was baseline disease severity. Patients with more severe disease at baseline had a lower discontinuation risk. There were significant improvements in functioning and well-being and non-significant improvements in therapeutic alliance and compliance. CONCLUSIONS: No significant difference was seen between discontinuation rates of the two formulations. Higher baseline severity was associated with a lower discontinuation rate.