Achieving lupus low-disease activity and remission states under belimumab in refractory systemic lupus erythematosus: time and organ involvement matter

We read with much interest the contribution of Oon et al 1 that was published recently in Annals of the Rheumatic Diseases, describing attainment of the lupus low-disease activity state (LLDAS) in a post-hoc analysis of the BLISS trials. At week 52, LLDAS was reached by 12.5% and 14.4% of patients treated with belimumab 10 mg/kg in BLISS-52 and BLISS-76, respectively. The authors conclude that LLDAS is a potential response indicator for future systemic lupus erythematosus (SLE) trials. As opposed to SLE responder index 4 (SRI4),2 which represents a change from baseline activity, LLDAS3 and remission4 are clinical states that should be targeted as they are associated with damage accrual reduction and include the notion of a low prednisone dose.5 Yet, these indicators should be further studied before being introduced into clinical trials. In particular, Oon et al ’s study lacks data on the time needed to achieve LLDAS and the clinical factors influencing its achievement. It is also important to consider the absence of relapse after an improvement of the disease. In this letter, we wish to provide additional data on the time needed, the probability of and the clinical predictors for achieving stable (ie, without subsequent relapse until month 12) LLDAS and remission state under belimumab. We included all patient with SLE treated with belimumab (intravenous 10 mg/kg on day 0, 14, 28 and then every 28 days) in our centre from March 2013 to May 2018 for an active disease despite standard therapy. Follow-up was …

[1]  E. Morand,et al.  Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus , 2019, Annals of the rheumatic diseases.

[2]  G. Alarcón,et al.  Remission and Low Disease Activity Status (LDAS) protect lupus patients from damage occurrence: data from a multiethnic, multinational Latin American Lupus Cohort (GLADEL) , 2017, Annals of the rheumatic diseases.

[3]  I. Bruce,et al.  A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS) , 2016, Annals of the rheumatic diseases.

[4]  L. Magder,et al.  Remission in systemic lupus erythematosus: durable remission is rare , 2016, Annals of the rheumatic diseases.

[5]  E. Morand,et al.  Definition and initial validation of a Lupus Low Disease Activity State (LLDAS) , 2015, Annals of the rheumatic diseases.

[6]  Gerald McGwin,et al.  Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. , 2012, Arthritis and rheumatism.

[7]  M. Petri,et al.  Novel evidence-based systemic lupus erythematosus responder index. , 2009, Arthritis and rheumatism.

[8]  Mimi Y. Kim,et al.  Combined oral contraceptives in women with systemic lupus erythematosus. , 2005, The New England journal of medicine.

[9]  D A Isenberg,et al.  Development and initial validation of an updated version of the British Isles Lupus Assessment Group ’ s disease activity index for patients with systemic lupus erythematosus , 2005 .

[10]  D. Symmons,et al.  The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. , 1996, Arthritis and rheumatism.

[11]  I. Bruce,et al.  Development and initial validation of an updated version of the British Isles Lupus Assessment Group ’ s disease activity index for patients with systemic lupus erythematosus , 2005 .