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Determinants of neu...
Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus : results from five phase III trials of belimumab
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- Palazzo, Leonardo (författare)
- Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
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- Lindblom, Julius (författare)
- Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden
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- Çetrez, Nurşen (författare)
- Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
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- Ala, Henri (författare)
- Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
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- Parodis, Ioannis, 1981- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden; Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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(creator_code:org_t)
- Oxford University Press, 2024
- 2024
- Engelska.
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Ingår i: Rheumatology. - : Oxford University Press. - 1462-0324 .- 1462-0332. ; 63:3, s. 798-808
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- OBJECTIVE: To identify determinants of neuropsychiatric (NP) flares in patients with systemic lupus erythematosus (SLE) treated for active SLE yet no ongoing severe NPSLE with non-biologic standard therapy plus belimumab or placebo.METHODS: We analysed data from five phase III trials (BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC, EMBRACE; N = 3638) after exclusion of patients with baseline NP BILAG A. Factors associated with NPSLE flare, defined as a new NP BILAG A or B, were investigated using Cox regression. In a subgroup analysis, we studied patients with baseline NP BILAG E for determinants of de novo NPSLE flare. Organ damage was assessed using the SLICC/ACR Damage Index (SDI). RESULTS: We documented 105 (2.9%) NPSLE flares. In multivariable analysis, male sex (HR = 2.37; 95% CI: 1.31-4.28; p = 0.004), baseline NP BILAG B-D (HR = 5.91; 95% CI: 3.86-9.06; p < 0.001), and increasing SDI scores (HR = 1.35; 95% CI: 1.21-1.50; p < 0.001) were strongly associated with NPSLE flare. Belimumab use yielded no association at any dose or administration form. In analysis of SDI domains, NP damage was the strongest determinant of NPSLE flare (HR = 3.25; 95% CI: 2.72-3.88; p < 0.001), holding true for cognitive impairment (HR = 14.29; 95% CI: 9.22-22.14; p < 0.001), transverse myelitis (HR = 21.89; 95% CI: 5.40-88.72; p < 0.001), and neuropathy (HR = 8.87; 95% CI: 5.59-14.09; p < 0.001). Male sex was the strongest determinant of de novo NPSLE flare (HR = 3.26; 95% CI: 1.51-7.04; p = 0.003).CONCLUSION: Male sex, NPSLE history, and NP damage were strong determinants of impending NPSLE flare. No clear protection or predisposition was conferred from add-on belimumab.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
Nyckelord
- Belimumab
- determinants
- flares
- neuropsychiatric
- systemic lupus erythematosus
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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