LIRE Project
Lupus Italian REgistry

LIRE Project

Project Leaders

Andrea Doria - UOC Reumatologia, Dipartimento di Medicina-DIMED, Università di Padova,
Gian Domenico Sebastiani - UOC Reumatologia, AO ‘San Camillo-Forlanini’, Roma,
Fabrizio Conti - Cattedra di Reumatologia, Università La Sapienza, Roma,


Over the past 10 years some new drugs have been introduced in the therapy of SLE such as Mycophenolate Mofetil and Rituximab, both used off-label, and more recently Belimumab, which officially entered the rheumatologist’s therapeutic arsenal after it was approved for SLE by the FDA and EMA. These drugs are changing the natural history of the disease and therefore there is the need to revise the prognostic paradigms and assess the impact they have on the health and quality of life of patients with SLE.

The innovative feature of the project

In recent years, registers have generated considerable interest, because they promote the evaluation of the impact of new drugs used in "real life". The extreme rigidity of the criteria for inclusion and exclusion and the treatment protocols used in randomised controlled trials (RCTs) does not, in fact, permit a complete evaluation of the effect of a drug used in daily clinical practice and therefore in unselected subjects treated for a longer period of time with respect to the study period. If set up properly, a register can provide very useful information and also complete the information that emerges from RCTs. For these reasons, the Italian Society of Rheumatology has proposed setting up an Italian multicentre registry of patients with SLE, which all rheumatology and non-rheumatology centres with experience in the treatment of these patients can access.


General objective

  • Describe the socio-demographic, clinical and serological characteristics of SLE patients in Italy treated with traditional therapy and/or biological drugs. Evaluate the efficacy and safety of current therapies.

Primary objectives

Cross-sectional phase:

  • Assess the permanent damage and comorbidities in the Italian patient population.

Prospective phase:

  • Analyse the impact of clinical and serological signs on the accumulation of permanent damage, complications, comorbidities, quality of life and survival of patients.

Secondary objectives

Cross-sectional phase:

  • Analyse the frequency of use of synthetic or biologic drugs currently available, evaluating any differences in relation to: clinical serological subset, co-morbidity and the centre of origin of the patient.

Prospective phase:

  • Evaluate the therapeutic strategies used in SLE patients in daily clinical practice: the reasons for their introduction, the duration of treatment and the reason why treatment was suspended;
  • Study the relationship between the drugs used and disease activity, cumulative damage, complications, comorbidities, and survival.