Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.
Prescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and/or autoimmune diseases.
Patients over 18 years
Enrolled in the French national social security system
Diagnosis of an inflammatory/autoimmune disease meeting internationally accepted classification criteria;
Clinical activity of their disease with biological and/or radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.
Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);
History of severe immunosuppression, HIV or HBsAg positive.
Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).
Have received live vaccines in the 3 months preceding the start of treatment.
Patients with refractory inflammatory and autoimmune diseases
Cohort
Prospective
Not listed
proportion of complete remission from the disease at week 24
The primary outcome will be the proportion of complete remission from the disease at week 24 : 1. absence of all clinical signs and symptoms ; 2. normalization of fibrinogen and CRP values; 3. absence of radiological signs of active disease (stable or improved imaging).
Evaluate the proportion of patients in clinical, biological or radiological remission
Evaluate the proportion of patients with clinical remission (endpoint #1 of the primary endpoint), biological remission (endpoint #2 of the primary endpoint) or radiological remission (endpoint #3 of the primary endpoint) at weeks 12 and 48 of the indicated treatment start.
Cumulative incidence of relapse (i.e., recurrence of clinical symptoms associated with biological and/or radiological inflammatory activity following complete remission)
Cumulative incidence of relapse (i.e., recurrence of clinical symptoms associated with biological and/or radiological inflammatory activity following complete remission) at weeks 12, 24, 36 and 52;
Cumulative incidence of remission according to primary endpoint definitions
Cumulative incidence of remission according to primary endpoint definitions at weeks 12, 36 and 52
Evaluate changes in median disease-specific activity scores
Evaluate changes in median disease-specific activity scores at weeks 12, 24, 36 and 52
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