To Örebro University

oru.seÖrebro University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Show others and affiliations
2024 (English)In: Rheumatology, ISSN 1462-0324, E-ISSN 1462-0332, Vol. 63, no 3, p. 798-808Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Oxford University Press, 2024. Vol. 63, no 3, p. 798-808
Keywords [en]
Belimumab, determinants, flares, neuropsychiatric, systemic lupus erythematosus
National Category
Rheumatology and Autoimmunity
Identifiers
URN: urn:nbn:se:oru:diva-106049DOI: 10.1093/rheumatology/kead249ISI: 001010366000001PubMedID: 37228034Scopus ID: 2-s2.0-85178279237OAI: oai:DiVA.org:oru-106049DiVA, id: diva2:1759483
Funder
Swedish Rheumatism Association, R-969696King Gustaf V Jubilee Fund, FAI-20200741Swedish Society of Medicine, SLS-974449Nyckelfonden, OLL-974804Region Stockholm, FoUI-955483Karolinska Institute
Note

Funding agencies:

Professor Nanna Svartz Foundation 202100436

Ulla and Roland Gustafsson Foundation 202126

Available from: 2023-05-26 Created: 2023-05-26 Last updated: 2024-03-22Bibliographically approved

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full textPubMedScopus

Authority records

Parodis, Ioannis

Search in DiVA

By author/editor
Parodis, Ioannis
By organisation
School of Medical Sciences
In the same journal
Rheumatology
Rheumatology and Autoimmunity

Search outside of DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 31 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf