Concerns have been raised that randomized placebo-controlled trials (RCTs) in non-radiographic axial spondyloarthritis (nr-axSpA) might be failing to identify patients that best show differences in clinical response rates between those receiving active drug and those receiving placebo therapies; in addition, some studies might even be showing spurious differences in responses to TNF and IL-17 inhibitor therapies. In particular, the most recent phase III RCTs in nr-axSpA have reported variable and generally lower response rates than observed in phase III trials of patients with ankylosing spondylitis and in trials conducted a decade ago in patients with early axSpA who were selected on the basis of axial inflammation evident on MRI scans. We argue that these observations at least partly reflect an RCT design that does not take full advantage of MRI to select patients who are responsive to therapy because the current MRI-based inclusion criteria cannot identify patients with axSpA with sufficient specificity. We propose that future studies should be designed using revised patient inclusion criteria based on expanded MRI evaluation and the application of data-driven definitions of a positive MRI for inflammatory and structural lesions typical of axSpA reported in an international multicentre analysis of MRI scans from the Assessment of SpondyloArthritis International Society (ASAS) classification cohort.
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Article Synopsis
- * The study evaluates the effectiveness and safety of various treatments for non-radiographic axial spondyloarthritis (nr-axSpA), including tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i), and Janus kinase inhibitors (JAKi).
- * A systematic review covered 10 randomized controlled trials with 2,418 participants, utilizing multiple databases and statistical software to analyze data on treatment efficacy and adverse events.
- * Results showed that certolizumab pegol was the most effective, followed by other treatments like golimumab and bimekizumab, with most therapies significantly improving symptoms compared to placebo; however, safety profiles varied among treatments.
Efficacy of TNF-α Inhibitors in the Treatment of nr-axSpA: A Systematic Review and Meta-Analysis Based on Randomized Controlled Trials.
Int Arch Allergy Immunol
June 2024
Emergency Medical Center, Ningbo Yinzhou No. 2 Hospital, Ningbo, China.
Introduction: A growing number of randomized controlled trials (RCTs) have demonstrated the effectiveness of tumor necrosis factor-α (TNF-α) inhibitors in treating non-radiographic axial spondyloarthritis (nr-axSpA). This study aimed to evaluate the efficacy of TNF-α inhibitors in the treatment of nr-axSpA.
Methods: PubMed, EMBASE, Web of Science, and the Cochrane Library databases were systematically searched for relevant RCTs using specific keywords up to June 2023.
Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials.
Arthritis Res Ther
February 2024
72Nd Street Medical Associates, Scarsdale, NY, USA.
Background: We report long-term, end-of-study program safety outcomes from 25 randomized clinical trials (RCTs) in adult patients with psoriasis (PsO), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) [including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)] who received ≥ 1 dose of Ixekizumab (IXE) over 5 years (PsO) or up to 3 years (PsA, axSpA).
Methods: This integrated safety analysis consists of data from patients who received any dose of IXE, across 25 RCTs (17 PsO, 4 PsA, 4 axSpA). Rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and selected adverse events (AEs) of interest were analyzed for all pooled studies by years of therapy and overall, through March 2022.
Secukinumab for children and adolescents with enthesitis-related arthritis and psoriatic arthritis: .
Expert Rev Clin Immunol
May 2024
Department of Paediatric Rheumatology, Bristol Royal Hospital for Children, Bristol, UK.
Introduction: Targeting IL-17A using Secukinumab, a humanized monoclonal immunoglobulin G1 (IgG1)/κ against IL-17A is a therapeutic option for immune-mediated disorders such as psoriasis and ankylosing spondylitis. The US Food and Drug Administration and the European Medicines Agency have approved it for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondylarthritis. Recently it has also been approved for use in children with severe plaque psoriasis, active psoriatic arthritis, and enthesitis-related arthritis.
View Article and Find Full Text PDFSafety of Upadacitinib in Immune-Mediated Inflammatory Diseases: Systematic Literature Review of Indirect and Direct Treatment Comparisons of Randomized Controlled Trials.
Adv Ther
February 2024
Division of Gastroenterology and Hepatology, Inflammatory Bowel Disease Unit, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Article Synopsis
- Immune-mediated inflammatory diseases, such as rheumatoid arthritis and Crohn's disease, significantly impact patients' quality of life, and upadacitinib is a new oral treatment option for these conditions.
- A systematic review assessed the safety of upadacitinib compared to other treatments by analyzing 25 randomized controlled trials published between 2018 and 2022.
- The majority of studies found no significant safety differences between upadacitinib and other treatments or placebo, though some reported mixed results regarding adverse events.
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