assessment of the clinical and medico-economic impact of sinnotest® in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid; Biological Therapy

Summary: rheumatoid arthritis (ra) is one of the main chronic inflammatory rheumatic diseases (rci), with a prevalence of about 0.4% of the population. first-line treatment with immunomodulators (synthetic and biological disease modifying anti-rheumatic drugs (sdmards) including methotrexate) is not sufficiently effective in 40% of cases. these patients are then treated with biological disease modifying anti-rheumatic drugs (bdmards) called biotherapies. as the use of these bio-drugs increases each year, they become a major public health and economic issue. their growth is only just beginning, as they are among the major providers of pharmaceutical innovation. there are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. this cost is 20 times higher than that of sdmards. however, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs. in the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. sinnotest® software, a predictive algorithm for responding to bdmards by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed ra of a first bdmard in the anti-tnf family.


Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis defined according to acr/eular 2010 or acr 1987 criteria. * patients in failure (patient insufficiently responding to anti-tnf treatment das28 \> 3.2 whether related to primary biotherapy failure, loss of efficacy (loss of response) or adverse event) of a first bdmard of the anti-tnf family (adalimumab, infliximab, etanercept, certolizumab or golimumab). * stability of synthetic fund processing for 3 months. * corticosteroids ≤ 0.1 mg/kg/day without cortisone assault within 3 months. * effective contraception for patients with reproductive capacity (oral contraceptive, intrauterine device, implant, surgical sterilization or abstinence). * patients who have dated and signed the consent form for the trial. * patients affiliated to a social security system. exclusion criteria: * contraindication to at least one of the following bdmards: rituximab and/or abatacept and/or adalimumab. * scheduled surgical intervention during the trial. * difficulties in understanding the french language. * cognitive function disorders (dementia such as alzheimer's, etc.). * patients who cannot be followed up at 12 months. * psycho-social instability incompatible with regular follow-up (homelessness, addictive behavior, a history of psychiatric pathology or any other comorbidity that would make free and informed consent impossible or limit adherence to the protocol). * persons referred to in articles l1121-5 to l1121-8 of the csp (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure). * patients currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.

Keywords: predictive software quality of life