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Efficacy of belimumab in patients with active systemic lupus erythematosus and concomitant antiphospholipid syndrome








Efficacy of belimumab in patients with active systemic lupus erythematosus and concomitant antiphospholipid syndrome


Pier Luigi Meroni


Istituto Auxologico Italiano, IRCCS, Laboratory of Immunorheumatology, Milan, Italy.






23 Jul 2019


Antiphospholipid syndrome (APS) is a rare disorder caused by the immune system and characterized by the development of venous and/or arterial thromboses, and pregnancy complications (mainly, recurrent fetal losses), in the presence of antiphospholipid antibodies (aPL). aPL are abnormal antibodies directed against phospholipids; their presence is associated with a hypercoagulability state, which means that the blood is more likely to clot. APS is often associated with other diseases, such as systemic lupus erythematosus (SLE), infections and malignancies.SLE is an autoimmune disorder characterized by extremely diverse clinical presentations. SLE can affect any organ, and is characterized by an unpredictable clinical course. Both APS and SLE are immune-mediated disorders, which means that they are caused by an alteration of the immune system, which attacks healthy tissues by mistake. Recently, a case report on three patients affected by APS associated to SLE reported the disappearance of aPL following belimumab treatment.Specifically, belimumab is a novel therapy that has been approved for patients with SLE, and that acts by decreasing the (improper) activation of the immune system.Furthermore, we reported for the first time the ability of belimumab to reduce aPL in 12 SLE patients, both in patients taking belimumab alone and in those taking belimumab in association with hydroxychloroquine (a drug that acts by reducing inflammation and decreasing the activation of the immune system).To date, evidence on the effect of belimumab on aPL is limited to these observational studies conducted on small cohorts of patients. Thus, the role of belimumab in APS patients should be further investigated on a wider population.Understanding the role of belimumab in reducing aPL would be of major clinical relevance for patients suffering APS. In fact, as previously mentioned, the presence of aPL is associated with an increased risk of blood clots and of heart diseases. Thus, reducing aPL, particularly in patients at major risk of cardiovascular events, would help controlling their risk of cardiac and cardiovascular complications. Thus, this study aims to assess the effects of belimumab on aPL concentrations among subjects diagnosed with APS associated to SLE, and to evaluate the effects of belimumab on the risk of cardiovascular events among subjects with APS associated to SLE.



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Statistical Analysis Plan