title: Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries.
abstract: OBJECTIVE
  Clinical registries have shown their effectiveness in capturing the long-term benefit of drugs in routine care. In France, two types of registry have been established to analyse the safety and efficacy of biological agents.
  
  
  METHODS
  The Research Axed on Tolerance of Biotherapies (RATIO) registry was designed to prospectively collect all cases of lymphoma and opportunistic infections occurring in patients receiving anti-TNF blockers for any indication. We also examined the results from nationwide prospective cohorts in order to investigate the safety and efficacy of rituximab (RTX), abatacept (ABA) and tocilizumab in RA and other autoimmune diseases.
  
  
  RESULTS
  Analysis of the RATIO registry demonstrated an increased risk of Legionella pneumophila infection in patients receiving anti-TNF therapy, a higher risk of tuberculosis [odds ratio (OR) (95% CI): 13.3 (2.6, 69.0) and 17.1 (3.6, 80.6) for infliximab and adalimumab vs etanercept, respectively], opportunistic infections and incidence of lymphoma, with mAb than with soluble-receptor anti-TNF. The characteristics of RA patients in RTX and ABA registries showed that some patients did not receive previous TNF blockers [20% in autoimmunity and RTX (AIR) and 13% in Orencia and RA (ORA)] and one-third of them were treated without concomitant DMARDs. Patients receiving RTX showed an increased proportion of severe infections (5.0/100 patient-years). Lung and cardiac comorbidities, extra-articular involvement and low immunoglobulin G before RTX were predictive factors of severe infections. In addition, the AIR registry suggested the effectiveness of RTX in patients with SLE.
  
  
  CONCLUSIONS
  The establishment of biological registries in rheumatic diseases, in France, with their different methods, has already provided additional data to controlled trials, mainly on the risk of severe infections and lymphoma.
authors.affiliation: Rheumatology Department, Hôpital Lapeyronie, University Paris-Sud 11 V, INSERM U1012, 371 avenue du Doyen G. Giraud, 34295 Montpellier Cedex 5, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.forename: Jacques-Eric
authors.initials: JE
authors.lastname: Gottenberg
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
mesh_terms: D000068879:Adalimumab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001327:Autoimmune Diseases / Q000188:drug therapy*; D001688:Biological Products / Q000009:adverse effects; D005260:Female; D005602:France; D006801:Humans; D007239:Infections / Q000139:chemically induced*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008223:Lymphoma / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D012042:Registries / Q000592:standards; D012307:Risk Factors; D000069283:Rituximab; D000079424:Tumor Necrosis Factor Inhibitors; D048069:Tumor Necrosis Factors / Q000009:adverse effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D001688:Biological Products; D000079424:Tumor Necrosis Factor Inhibitors; D048069:Tumor Necrosis Factors; D000069283:Rituximab; D000068879:Adalimumab; C502936:tocilizumab