Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus.
Acthar gel
Autoimmune disease
Biomarker
Cytokine
Glucocorticoid
Immune cell
Repository corticotropin injection
Systemic lupus erythematosus
Journal
Rheumatology and therapy
ISSN: 2198-6576
Titre abrégé: Rheumatol Ther
Pays: England
ID NLM: 101674543
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
11
02
2021
accepted:
13
07
2021
pubmed:
4
9
2021
medline:
4
9
2021
entrez:
3
9
2021
Statut:
ppublish
Résumé
We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids. Adults with active SLE and moderate to severe rash and/or arthritis were enrolled in the primary study. Patients had active SLE despite treatment with stable glucocorticoids, antimalarials, and nonsteroidal anti-inflammatory drugs and/or immunosuppressants. Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24. Blood samples were analyzed for serum cytokines and complement proteins using enzyme-linked immunosorbent or Luminex assays and for circulating leukocytes using flow cytometry. Biomarker levels were reported as percentages of the baseline and were further evaluated in subgroups stratified by baseline SLE Disease Activity Index-2000 (SLEDAI-2K) scores (< 10 vs. ≥ 10), baseline anti-double-stranded DNA levels (< 15 IU/mL vs. ≥ 15 IU/mL), and BILAG-based Combined Lupus Assessment (BICLA) responses at week 20 and 24. RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo. RCI treatment also resulted in lower levels of CD19 RCI may reduce inflammation through B cell immunomodulation in patients with persistently active SLE, particularly in those with higher disease activity. ClinicalTrials.gov identifier NCT02953821.
Identifiants
pubmed: 34478124
doi: 10.1007/s40744-021-00351-7
pii: 10.1007/s40744-021-00351-7
pmc: PMC8572274
doi:
Banques de données
ClinicalTrials.gov
['NCT02953821']
Types de publication
Journal Article
Langues
eng
Pagination
1871-1886Informations de copyright
© 2021. The Author(s).
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