Objectives: Glucocorticoid sparing is a key priority for SLE management. We evaluated the effects of sustained glucocorticoid tapering in patients with SLE.
Material And Methods: This was a post hoc analysis of the randomized, placebo-controlled, 52-week phase 3 Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-1 and TULIP-2 trials of anifrolumab (300 mg i.v. once every 4 weeks for 48 weeks) plus standard therapy in patients with moderate to severe SLE. In a cohort of patients receiving glucocorticoids (prednisone or equivalent) 10 mg or more per day at baseline, we assessed changes in glucocorticoid dosage, patient-reported outcomes (PROs) and safety. Outcome measures were compared between sustained glucocorticoid taper responders (7.5 mg or less per day by week 40 sustained through week 52) and non-responders, regardless of treatment group, and between patients receiving anifrolumab or placebo.
Results: Among the 726 patients in the TULIP trials, 375 patients received glucocorticoids 10 mg or more per day at baseline, and of these, 155 (41%) patients were sustained glucocorticoid taper responders. Compared with non-responders (n = 220), sustained glucocorticoid taper responders reduced their mean cumulative glucocorticoid dose by 32%, improved PRO scores, reduced blood pressure and experienced fewer serious adverse events. Sustained glucocorticoid tapering was achieved by 51% (96/190) of patients receiving anifrolumab vs 32% (59/185) receiving placebo. Compared with placebo, more anifrolumab-treated patients achieved both sustained glucocorticoid taper and reduced overall disease activity [38% (72/190) vs 23% (43/185)].
Conclusions: Sustained glucocorticoid tapering is associated with clinical benefits. Anifrolumab treatment has potential to reduce disease activity and glucocorticoid exposure, a key goal of SLE management.
Study Registration: ClinicalTrials.gov identifier: NCT02446912 and NCT02446899.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10070065 | PMC |
| http://dx.doi.org/10.1093/rheumatology/keac491 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Characterizing Protracted Febrile Myalgia: Fasciitis and Vasculitis of the Fascia and Muscle as Novel Histopathological Features.
J Clin Med
December 2024
Department of Internal Medicine, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, 08036 Barcelona, Spain.
: Protracted febrile myalgia (PFM) is a rare but severe form of myalgia mainly occurring in pediatric patients with familial Mediterranean fever (FMF). PFM imaging and histopathological data remain scarce. : A comprehensive clinical, imaging, and histopathological characterization of PFM was performed by retrospectively analyzing a reference center cohort of adult patients with FMF and myalgia, and by a PubMed search of well-described cases with PFM.
View Article and Find Full Text PDFPatient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial.
Lancet Haematol
January 2025
University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Background: In CARTITUDE-4, ciltacabtagene autoleucel (cilta-cel) significantly improved progression-free survival (primary endpoint; previously reported) versus standard of care in patients with relapsed, lenalidomide-refractory multiple myeloma. We report here patient-reported outcomes.
Methods: In the ongoing, phase 3, open-label CARTITUDE-4 study, patients were recruited from 81 sites in the USA, Europe, Asia, and Australia, and were randomly assigned 1:1 to cilta-cel (target, 0·75 × 10 CAR-T cells/kg) or standard of care (daratumumab, pomalidomide, and dexamethasone; pomalidomide, bortezomib, and dexamethasone).
Application of Nanomaterials Targeting Immune Cells in the Treatment of Chronic Inflammation.
Int J Nanomedicine
December 2024
Department of Oral Implantology, Hospital of Stomatology, Jilin University, Changchun, 130021, People's Republic of China.
Article Synopsis
- Chronic inflammation is linked to various diseases and is characterized by prolonged immune cell activation, resulting in tissue damage.
- Despite the effectiveness of current anti-inflammatory medications, they often have side effects due to non-specific targeting.
- Nanoparticle drug delivery shows promise for targeted therapy in inflammation, but improvements are needed to specifically target different immune cell types for enhanced therapeutic effects.
Severe Polymyalgia Rheumatica-Like Syndrome Induced by Immune Checkpoint Inhibitor: A Case Report and Literature Review.
Cureus
November 2024
Division of Medical Oncology, Department of Medicine, Showa University School of Medicine, Tokyo, JPN.
Immune checkpoint inhibitors (ICIs) have dramatically improved the prognosis of patients with cancers. However, ICIs can provoke systemic toxicities, which are known as immune-related adverse events (irAEs). Polymyalgia rheumatica (PMR)-like syndrome induced by ICI is one of the most common rheumatic irAEs.
View Article and Find Full Text PDFA phase 1/2 safety and efficacy study of TAK-754 gene therapy: The challenge of achieving durable factor VIII expression in haemophilia A clinical trials.
Haemophilia
December 2024
Investigative Toxicology, Takeda Development Center of the Americas, Cambridge, USA.
Introduction: Haemophilia A is an X-linked bleeding disorder resulting from a deficiency of factor VIII (FVIII). To date, multiple gene therapies have entered clinical trials with the goal of providing durable haemostatic protection from a single dose. TAK 754 (BAX 888) is an investigational AAV8-based gene therapy containing a FVIII transgene.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!