Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases

Completed

• Conditions: Immunologic and Inflammatory Diseases
• Interventions: Biological: Blood samples

• Registration Number: NCT02280902
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Infections represent the first cause of death and of morbidity in people treated for immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these infections are poorly understood. There is no recommendation for the prevention and treatment of infections in this particular field.

Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first year after the beginning of the treatment. Thus, the main objective of the study is to describe the incidence and risk-factors for infections in people treated with such agents for immunologic and inflammatory diseases.

Detailed Description

Monitoring of neutrophils, lymphocytes, immune activation markers, immunoglobulins have not been prospectively studied in such patients. Preliminary retrospective studies have shown that total lymphopenia was independently associated with an increased risk of infections. A previous retrospective study from our group have also shown that total lymphopenia and CD3- lymphopenia three months after the beginning of rituximab was associated with infections.

The determinants of infections occurring during the course of immune and inflammatory diseases treated with corticoids and immunosuppressive drugs or biotherapy are probably multiples. We hypothesized that the following variables may have an impact on the risk of infections in those patients: Epidemiological: gender, social situation, Clinical: causal disease, comorbidities, vaccination status, Therapeutic: type and doses of corticosteroids and immunosuppressive drugs/biotherapy, prevention treatment Biological : neutrophils, total lymphocytes, CD4-T lymphocytes, CD8-T lymphocytes, B lymphocytes, immune activation (HLA-DR+ lymphocytes), CD5 and CD19 lymphocytes, CD27/IgD lymphocytes, immunoglobulins IgA, IgM, IgG.

On the other side, the impact of infection on the clinical course of immunologic or inflammatory disease have been poorly described and will be documented by this longitudinal study.

After inclusion in the present study, patients will be followed on a 30 months period and monitored at M3, M6, M12, M24 to describe the impact of treatment on clinical and biological variables. Every clinical event will be prospectively reported and validated by a specific committee.

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-11-02
• Study Start: 2016-02-16
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Age > 18 years
• Immune or inflammatory disease : Lupus, antiphospholipid syndrome, Sjogren syndrome, inflammatory myositis, immunologic thrombopenic purpura, autoimmune hemolytic anemia, Evan's syndrome, systemic vasculitis, Behcet disease.
• Indication of corticosteroid therapy > 20 mg for at least 3 months and/or immunosuppressive or biologic agent.
• Information consent

Exclusion Criteria

• Previous treatment with immunosuppressive or biological agents, or cumulative dose of steroids > 1g last 6 months
• Splenectomy
• Pregnancy
• Evoluting Cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with immunologic and inflammatory diseases	Blood samples	Patient treated with corticosteroids, immunosuppressive drugs or biotherapy for immunologic and inflammatory diseases

Primary Outcome Measures

Name	Time	Method
Viral, bacterila, fungal or parasitic infection leading to hospitalization	30 months after the inclusion

Secondary Outcome Measures

Name	Time	Method
Biological and immunological markers	Each 6 months from baseline for 30 months	The following items will be assessed every 6 months : total White blood cell CD3 CD4 CD8 HLA-DR+ B cells CD19+ B cells CD5+/- CD27/IgD NK cells IgA, IgM, IgG levels
Morbidity	Each 6 months from baseline for 30 months

Trial Locations

Locations (7)

Service de Médecine Interne - CH d'Agen; 🇫🇷 Agen, France

service de médecine interne - CH de Libourne; 🇫🇷 Libourne, France

Service de Médecine Interne - CHU de Limoges; 🇫🇷 Limoges, France

Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André; 🇫🇷 Bordeaux, France

Service de Médecine Interne - CH de Pau; 🇫🇷 Pau, France

service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5); 🇫🇷 Toulouse, France

service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7); 🇫🇷 Toulouse, France