Clinical trial design in systemic lupus erythematosus: lessons learned and                 future directions

Abstract Objective SLE is characterized by relapses and remissions. We aimed to describe the frequency, type and time to flare in a cohort of SLE patients. Methods SLE patients with one or more ‘A’ or ‘B’ BILAG-2004 systems meeting flare criteria (‘new’ or ‘worse’ items) and requiring an increase in immunosuppression were recruited from nine UK centres and assessed at baseline and monthly for 9 months. Subsequent flares were defined as: severe (any ‘A’ irrespective of number of ‘B’ flares), moderate (two or more ‘B’ without any ‘A’ flares) and mild (one ‘B’). Results Of the 100 patients, 94% were female, 61% White Caucasians, mean age (s.d.) was 40.7 years (12.7) and mean disease duration (s.d.) was 9.3 years (8.1). A total of 195 flares re-occurred in 76 patients over 781 monthly assessments (flare rate of 0.25/patient-month). There were 37 severe flares, 32 moderate flares and 126 mild flares. By 1 month, 22% had a mild/moderate/severe flare and 22% had a severe flare by 7 months. The median time to any ‘A’ or ‘B’ flare was 4 months. Severe/moderate flares tended to be in the system(s) affected at baseline, whereas mild flares could affect any system. Conclusion . In a population with active SLE we observed an ongoing rate of flares from early in the follow-up period with moderate–severe flares being due to an inability to fully control the disease. This real-world population study demonstrates the limitations of current treatments and provides a useful reference population from which to inform future clinical trial design.

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Effect of low-level gallium aluminum arsenide laser therapy on the chewing performance and pain perception of patients with systemic lupus erythematosus: A randomized controlled clinical trial

CRANIO® ◽

10.1080/08869634.2021.1971888 ◽

2021 ◽

pp. 1-10

Author(s):

Merve Benli ◽

Olivier Huck ◽

Mutlu Özcan

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trial ◽

Lupus Erythematosus ◽

Pain Perception ◽

Aluminum Arsenide ◽

Controlled Clinical Trial ◽

Gallium Aluminum Arsenide ◽

Randomized Controlled Clinical Trial ◽

Systemic Lupus ◽

Randomized Controlled

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Lessons learned from bone marrow failure in systemic lupus erythematosus: Case reports and review of the literature

Seminars in Arthritis and Rheumatism ◽

10.1016/j.semarthrit.2017.12.004 ◽

2018 ◽

Vol 48 (1) ◽

pp. 90-104 ◽

Cited By ~ 2

Author(s):

Erik Anderson ◽

Bhakti Shah ◽

Anne Davidson ◽

Richard Furie

Keyword(s):

Systemic Lupus Erythematosus ◽

Bone Marrow ◽

Lupus Erythematosus ◽

Case Reports ◽

Bone Marrow Failure ◽

Lessons Learned ◽

Review Of The Literature ◽

Systemic Lupus ◽

Systemic Lupus Erythematosus Case

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FRI0371 A Comparison of Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) TRIAL Design: Ways to Improve Positive Trials in Sle:

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2014-eular.2728 ◽

2014 ◽

Vol 73 (Suppl 2) ◽

pp. 521.1-521

Author(s):

A. Miles ◽

J.E. Pope

Keyword(s):

Rheumatoid Arthritis ◽

Systemic Lupus Erythematosus ◽

Lupus Erythematosus ◽

Trial Design ◽

Systemic Lupus

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Effect of vitamin D supplementation on disease activity (SLEDAI) and fatigue in Systemic Lupus Erythematosus patients with hipovitamin D: An Open Clinical Trial

Indonesian Journal of Rheumatology ◽

10.37275/ijr.v8i2.59 ◽

2018 ◽

Vol 8 (2) ◽

Author(s):

Achmad Rifa’i ◽

Handono Kalim ◽

Kusworini Kusworini ◽

Cesarius Singgih Wahono

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trial ◽

Vitamin D ◽

Placebo Group ◽

Disease Activity ◽

Lupus Erythematosus ◽

Vitamin D Supplementation ◽

Control Group ◽

Systemic Lupus ◽

Significant Difference

Background : Low level of vitamin D impact the disease activity and the degree of fatigue in SLE patients. This study aims to determine the effect of vitamin D supplementation on disease activity and fatigue condition in Systemic Lupus Erythematosus (SLE) patients with hipovitamin D.Methods: We performed an open clinical trial. Subjects were randomized into two different groups (supplementation or placebo) using simple random sampling. The treatment group got vitamin D3 softgel/ cholecalciferol 1200 IU/day or 30 mg/day, while the control group gotplacebo for 3 months. SLEDAI scores and FSS scores were calculated at pre and posttreatment.Results: There were 20 subjectsfor supplementation group and 19 subjects in the placebo group. From this study, before and after treatment, we found a significant difference of mean level of vitamin D in supplementation group (p=0.000), and no significant difference inpatients with placebo (p=0.427). Moreover, from the SLEDAI score analysis, observed a significant difference bothin the supplemented group (p=0.000) and the placebo group (p=0.006). FSS scores significantly different in the supplemented group (p=0.000). Incorrelation test,there was a negative correlation (r=-0763) between vitamin D level and disease activity (SLEDAI), and both showing stastistical significance between thepre supplementation (p=0.000) and post supplementation (r=-0846; p=0.000). Similarly to theFSS scores, there was a meaningfulnegative correlation (r=-0.931, p=0.000) between the level of vitamin D with FSS scores pre and post supplementation (r=-0.911; p= 0.000). Furthermore, there was a significant correlation between disease activity (SLEDAI) pre supplementation with fatigue condition pre supplementation (r=0.846; p = 0.000) and postsupplementation (r=0.913; p= 0.000).Conclusion: The supplementation of vitamin D 1200 IU per day in patients with SLE improve disease activity and degree of fatigue. Keywords: vitamin D, disease activity, fatigue, SLE

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