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Patient-reported outcomes in neuropsychiatric SLE: Post hoc analysis of four phase III trials of belimumab
Around 20% of patients with systemic lupus erythematosus (SLE) experience primary neuropsychiatric (NP) events, known as neuropsychiatric SLE (NPSLE). However, our understanding of the impact of NPSLE on patient-reported outcomes is limited.
Nikolopoulos, et al. recently published a post-hoc analysis of four phase III trials of belimumab in Rheumatology, in which they assessed the impact of neuropsychiatric involvement on patient-reported outcomes in patients with SLE.1 Here, we summarize their key findings.
Methods
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Data from four phase III trials (BLISS-52 [NCT00424476], BLISS-76 [NCT00410384], BLISS-SC [NCT01484496], EMBRACE [NCT01632241]) were analyzed.
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Patients with NP-British Isles Lupus Assessment Group (NP-BILAG) A/B/C/D or score in any descriptor of the NPSLE Disease Activity Index 2000 at baseline were categorized as having NPSLE.
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Further, patients were subgrouped as having active NPSLE if scored A/B in the neuropsychiatric domain of BILAG and/or any neuropsychiatric descriptor scored in the SLE Disease Activity Index-2000.
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Patients were subgrouped as having inactive NPSLE patients if had a BILAG score C/D in the neuropsychiatric domain and no neuropsychiatric descriptor scored in the SLE Disease Activity Index-2000.
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Patients with NP-BILAG E were categorized within non-NPSLE.
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Health-related quality of life (HRQoL) was assessed using three instruments:
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Study Short Form 36 (SF-36);
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Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale, and
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the three-level version of the EuroQol research foundation 5-dimension (EQ-5D-3L).
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‘No problems’ in all EQ-5D dimensions indicated Full Health State (FHS).
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Frequency of HRQoL outcomes were assessed in patients with active vs inactive NPSLE.
Key findings
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A total of 2,968 patients were included in the analysis (non-NP SLE, n = 2,618; NPSLE, n = 350).
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Mean age at baseline was 38.2 years and 94.6% of patients were female.
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Patients with NPSLE vs non-NPSLE reported lower SF-36 physical component summary, SF-36 mental component summary, EQ visual analogue scale, and FACIT-F scores (Figure 1).
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Significant differences were seen in all SF-36 subscales, namely physical functioning, role physical, bodily pain, general health, social functioning, vitality, role emotional, and mental health (p < 0.001).
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The EQ-5D utility index scores were significantly worse in patients with NPSLE vs those with non-NPSLE (0.68 vs 0.75; p < 0.001).
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The proportion of patients experiencing FHS was lower within the NPSLE group compared with the non-NPSLE group (3.3% vs 14.5%; p < 0.001).
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A significantly lower proportion of patients with NPSLE reported no problems vs moderate or major problems in different dimensions of EQ-5D compared with the non-NPSLE group (Figure 2).
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Patients with active NPSLE reported no significant differences in SF-36, FACIT-F, EQ visual analogue scale, EQ-5D utility index score, and EQ-5D FHS frequencies compared with those with prior but currently inactive NPSLE.
Figure 1. HRQoL between patients with NPSLE and non-NPSLE*
EQ-VAS, EuroQol visual analogue scale; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; MCS, mental component summary; NPSLE, neuropsychiatric systemic lupus erythematosus; PCS, physical component summary; SF-36, Study Short Form 36.
*Adapted from Nikolopoulos, et al.1
Figure 2. Odds of having no problems vs moderate/major problems in different dimensions of EQ-5D in NPSLE vs non-NPSLE*
CI, confidence interval; EQ-5D, EuroQol research foundation 5-dimension; NPSLE, neuropsychiatric systemic lupus erythematosus.
*Data from Nikolopoulos, et al.1
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Key learnings |
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References
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