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SLE low-disease definition receives prospective validation

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New definition is a great step forward

Having a validated, formal definition of low disease activity in patients with systemic lupus erythematosus will be very helpful to clinicians and patients with this disease. The lack of such a widely accepted definition of a treatment target until now has been a significant issue that had made it more challenging to advise and treat patients.

The concept of a low disease state has been much easier to define in other rheumatic diseases, but lupus has posed a major challenge because of its very heterogeneous presentation. This heterogeneity has led to the creation of several measures of disease activity as well as multiple serologic parameters that also help define disease activity. It’s unrealistic to expect most lupus patients to be in a low disease activity state all the time.

Dr. Lisa R. Sammaritano, rheumatologist, Hospital for Special Surgery, New York Mitchel L. Zoler/MDedge News

Dr. Lisa R. Sammaritano

Validation of a reasonable definition of low activity is a great, pragmatic step forward for our field that will help clinicians better care for their patients with systemic lupus erythematosus.

Lisa R. Sammaritano, MD , is a rheumatologist at the Hospital for Special Surgery and Cornell University in New York. She had no disclosures. She made these comments in an interview.



– The long path toward a validated definition of low disease activity in patients with systemic lupus erythematosus may be nearing an end as a definition first proposed more than 5 years ago received validation with data from more than 1,700 patients in a prospective, multicenter study.

Dr. Vera Golder, rheumatologist, Monash University, Melbourne Mitchel L. Zoler/MDedge News

Dr. Vera Golder

The next step is to test this definition in treat-to-target intervention studies, and to apply the definition in other clinical trials as well as in routine clinical practice, Vera Golder, MD, said at the annual meeting of the American College of Rheumatology.

The tested definition has five elements that a patient needs to achieve to be considered in a lupus low disease activity state (LLDAS):

• A systemic lupus erythematosus (SLE) disease activity index (SLEDAI) score of 4 or less with no major organ involvement.

• No new disease activity.

• A physician’s global assessment of the patient of 1 or less on a 0-3 scale.

• Maintenance on a prednisolone dosage of 7.5 mg/day or less.

• Maintenance on a standard immunosuppressive regimen.

The Asia Pacific Lupus Collaboration (APLC) first proposed this definition of LLDAS in 2013 (Ann Rheum Dis. 2013 June;72[Suppl 3]:THU0298), and was the organization behind the latest test of its validity. The APLC based its LLDAS definition on recommendations made by an international working party (Ann Rheum Dis. 2014 June;73[6]:958-67).

The APLC prospectively collected data from 1,735 SLE patients at 13 centers in eight countries during May 2013–December 2016, with a median follow-up of 2.2 years. During that time, 78% of the patients achieved the LLDAS at least once. Two-thirds of the patients had at least one sustained period of LLDAS of at least 3 months, and overall the enrolled patients spent 69% of the time in the LLDAS, reported Dr. Golder, a rheumatologist at Monash University in Melbourne.

The validation analysis she described focused on examining the correlation between the amount of time that patients spent in the defined LLDAS and their subsequent clinical outcomes. The analysis showed that when patients were in the LLDAS their rate of subsequent flare or damage accrual was substantially reduced.

Patients in the LLDAS for at least half the time had a 51% reduced rate of subsequent flare and a 47% reduced rate of subsequent damage accrual, she reported. Patients with a LLDAS of 3-6 months had a 57% reduced rate of damage accrual. As time spent in continuous LLDAS continued to increase the rate of subsequent damage accrual continued to drop until the duration reached more than 9 months, at which point the rate of subsequent damage fell to nearly 90% lower than that of patients without this amount of sustained LLDAS. Patients with LLDAS sustained for more than 9 months and as long as 12 months had an 86% reduction in subsequent damage accrual. Periods of sustained LLDAS that extended longer than a year continued to maintain a nearly 90% reduced rate of damage accrual, Dr. Golder said.

The Asia Pacific Lupus Collaboration has received grants from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, and UCB. Dr. Golder had no disclosures.

SOURCE: Golder V et al. Arthritis Rheumatol. 2018;70(Suppl 10): Abstract 2786.

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