PMS43 Efficacy And Safety Of Pharmaceutical Treatments For Systemic Lupus Erythematosus (SLE): A Systematic Literature Review (SLR) Of Randomized Controlled Trials (RCTs)

Objective In this study, we aimed to assess the relative efficacy and safety of intravenous (IV) or subcutaneous (SC) belimumab compared with those of placebo in patients with active systemic lupus erythematosus (SLE). Methods We performed a Bayesian network meta-analysis to combine the direct and indirect evidence from randomized controlled trials (RCTs) examining the efficacy and safety of belimumab 1 mg/kg and 10 mg/kg IV administration, and belimumab 200 mg SC injection, and placebo in patients with active SLE despite having received standard therapy. Results Five RCTs (3460 patients) met the inclusion criteria. The SLE Responder Index (SRI) response rate at week 52 was significantly higher in the belimumab 10 mg/kg group than in the placebo group (OR 2.63, 95% CrI 2.14–3.23). Similarly, the SRI response rates were significantly higher in the belimumab 1 mg/kg, and belimumab 200 mg SC groups than in the placebo group (OR 2.42, 95% CrI 1.90–3.09; OR 1.71, 95% CrI 1.27–2.29). Ranking probability based on surface under the cumulative ranking curve (SUCRA) indicated that belimumab 10 mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA = 0.9174), followed by belimumab 1 mg/kg (SUCRA = 0.7338), belimumab 200 mg SC (SUCRA = 0.3487), and placebo (SUCRA = 0.0000). However, a sensitivity test by omitting one outlier study showing low SRI response rate compared with the other three studies (11% vs. 33%, 40%, 48%) showed that belimumab 200 mg SC and belimumab 10 mg/kg had the highest probability of being the best treatment for achieving the SRI response (SUCRA = 0.7903, SUCRA = 0.7456), followed by belimumab 1 mg/kg, and placebo. The number of serious adverse events (SAEs) did not differ significantly among the four treatment options. Conclusions Belimumab at 1 and 10 mg/kg IV and belimumab 200 mg SC in combination with standard therapy was an efficacious intervention for active SLE, and was not associated with a significant risk of SAEs.

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Learning from past mistakes: assessing trial quality, power and eligibility in non-renal systemic lupus erythematosus randomized controlled trials

Rheumatology ◽

10.1093/rheumatology/ken230 ◽

2008 ◽

Vol 47 (9) ◽

pp. 1367-1372 ◽

Cited By ~ 13

Author(s):

S. Y. Yuen ◽

J. E. Pope

Keyword(s):

Systemic Lupus Erythematosus ◽

Randomized Controlled Trials ◽

Lupus Erythematosus ◽

Controlled Trials ◽

Systemic Lupus ◽

Randomized Controlled ◽

Trial Quality

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Non-pharmacologic therapies for systemic lupus erythematosus

Lupus ◽

10.1177/0961203319841435 ◽

2019 ◽

Vol 28 (6) ◽

pp. 703-712 ◽

Cited By ~ 5

Author(s):

M Fangtham ◽

S Kasturi ◽

R R Bannuru ◽

J L Nash ◽

C Wang

Keyword(s):

Quality Of Life ◽

Systemic Lupus Erythematosus ◽

Randomized Controlled Trials ◽

Lupus Erythematosus ◽

Psychological Interventions ◽

Controlled Trials ◽

Systemic Lupus ◽

Randomized Controlled ◽

Pharmacologic Therapies

Background Non-pharmacologic therapies have been deemed as potentially beneficial for patients with systemic lupus erythematosus. We conducted an updated review to determine the effects of these therapies to inform practice. Methods A literature search was performed using PubMed (MEDLINE), EMBASE, Cochrane, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Google Scholar from inception until August 2018. We included randomized controlled trials of non-pharmacologic therapies in systemic lupus erythematosus patients with sample size ≥10. Systemic lupus erythematosus was defined by 1982 or 1997 American College of Rheumatology criteria. Studies were synthesized separately by patient-reported outcomes and disease activity. Due to the heterogeneity of interventions and comparisons, a meta-analysis was not performed. Results A total of 15 randomized controlled trials involving 846 participants met the inclusion criteria. Of the 15 trials, eight used exercise interventions, six used psychological interventions (one group psychotherapy, three cognitive behavioral therapies, one psychoeducation, one mindfulness-based cognitive therapy) and one used electro-acupuncture. Five of 15 studies utilized control groups consisting of usual medical care. Other studies included control interventions of relaxation, attention placebo, symptom monitoring support, education, minimal needling, isotonic and resistance exercise. Compared with the control conditions, non-pharmacological interventions were associated with a significant improvement in fatigue in three out of six studies. Three out of eight studies reported improved anxiety and depression, and one study reported improved pain after interventions. Seven out of 11 studies reported improvement in overall quality of life in at least one domain of the Short-Form Health Survey. Of note, no studies demonstrated an improvement in disease activity after 5–52 weeks of non-pharmacological therapies. Conclusion This review showed promising results for physical exercise and psychological interventions as adjuncts to traditional medical therapy for improvement in fatigue, depression, pain and quality of life for systemic lupus erythematosus. Further high-quality randomized controlled trials with longer follow-up periods are warranted.

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