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European Congress of Rheumatology, EULAR 2024 | News | Updates | iPharmaCenter

New Study Identifies Corticosteroid Management as Predictors of Organ Damage in Children with Lupus

Childhood-onset systemic lupus erythematosus (cSLE) is a chronic and severe autoimmune condition that can lead to early organ damage. Identifying specific predictors for this damage is crucial for improving patient outcomes. At the 2024 congress of the European Alliance of Associations for Rheumatology (EULAR), a session on pediatric rheumatology presented new research on the factors linked to organ damage in cSLE, focusing on corticosteroid use and maintaining low disease activity.

cSLE is a rare multisystem disorder with significant morbidity, and evidence-based guidelines for management are limited, often relying on clinical expertise. The EULAR/ACR-2019 criteria have shown sensitivity in cSLE patients, potentially allowing for earlier detection of those with major organ involvement. However, pinpointing specific predictors in this vulnerable group is essential to prevent long-term damage.

The new research presented at the EULAR 2024 congress aimed to identify how clinical, demographic, and treatment variables correlate with organ damage in cSLE.

The study involved 430 children participating in the UK JSLE Cohort Study. Analyses were conducted across the entire cohort and within two subgroups based on disease activity: low activity and moderate-to-high activity. Over a median follow-up period of 46 months, 23% of the children experienced organ damage. Across the entire cohort, multivariable analyses identified three factors associated with damage accrual: exposure to methylprednisolone, time-adjusted mean Physician’s Global Assessment (PGA) score, and Adjusted Mean SLE Disease Activity Index (AMS) score.

In the moderate-to-high disease activity subgroup, 28.1% experienced damage, with the same three factors serving as predictors. In the low disease activity subgroup, 20.5% accrued new damage, with methylprednisolone exposure and time-adjusted mean PGA score being significant predictors, but not AMS score.

This study underscores the significant role of corticosteroid exposure as a potentially modifiable risk factor in cSLE and suggests a need to review pediatric dosage limits, which often exceed adult recommendations. Additionally, a direct link was found between disease activity and damage, with each 1-unit increase in the SLE Disease Activity Index (SLEDAI) raising the risk of damage by 13–15% in those with moderate-to-high activity. This was not observed in patients with an AMS of 4 or less, indicating that maintaining low disease activity through treat-to-target strategies could substantially reduce the risk of damage.

These findings highlight the need for updated treatment protocols that limit corticosteroid use while effectively managing disease activity in children with cSLE.


New Research Highlights Potential of Interferon Signature in Diagnosing and Managing Pediatric Sjögren’s Disease

Diagnosing Sjögren's disease in children is challenging due to its atypical clinical presentation and limited research on the condition in this age group. While multiple immune response pathways have been identified in adults, studies focusing on pediatric patients are scarce. At the 2024 congress of the European Alliance of Associations for Rheumatology (EULAR) in Vienna, new research was presented highlighting the potential role of the blood interferon signature in diagnosing and categorizing pediatric Sjögren's disease.

Sjögren's disease is uncommon in children and presents differently than in adults. For instance, pediatric patients are less likely to exhibit sicca symptoms but more frequently experience parotid gland swelling and fever. The recent study aimed to uncover dysregulated molecular pathways in children with Sjögren's by comparing the transcriptome of peripheral blood cells from 18 patients and 23 controls using differential gene expression and pathway analysis.

The study involved whole transcriptome analysis of blood samples and measured the expression of interferon-stimulated genes (ISG) in both blood and parotid gland tissue samples. Researchers identified 247 differentially expressed genes between patients and controls, with 181 genes upregulated and 66 downregulated. Gene set enrichment analysis revealed that gene sets associated with interferon-gamma and -alpha response, inflammatory response, allograft rejection, fatty acid metabolism, and oxidative phosphorylation were enriched.

Elevated ISG expression was observed in 72% of children with Sjögren's disease. These patients also had positive antinuclear antibodies, with 92% testing positive for anti-SSA/Ro and rheumatoid factor, although none had elevated C-reactive protein (CRP). Conversely, patients without elevated ISG expression were less frequently positive for antinuclear antibodies, none tested positive for anti-SSA/Ro or rheumatoid factor, but they more often had elevated CRP and fever.

Additionally, ISG expression was noted in the parotid gland tissue of children with Sjögren's disease, correlating positively with ISG expression in blood samples. These findings underscore the potential of using interferon signatures to improve the diagnosis and stratification of pediatric Sjögren's disease, indicating that further research is warranted to explore these associations.


New Insights from ComOA Study on Osteoarthritis and Comorbid Conditions Enhance Disease Management

Osteoarthritis is the most prevalent form of arthritis globally, leading to a rising burden of disability and increased healthcare usage. Recently, there has been growing attention to its association with various comorbid conditions.

In the 2023 update of their osteoarthritis management recommendations, the European Alliance of Associations for Rheumatology (EULAR) recognizes osteoarthritis as a serious disease with significant impacts on individuals and society. However, optimal management is not provided to most osteoarthritis patients, highlighting a significant unmet need, especially considering the presence of additional systemic comorbidities.

To delve deeper into this issue, the ComOA study combined case-control and cohort studies involving over 3 million primary care patients in the UK, Netherlands, Sweden, and Spain. The findings, presented at the 2024 EULAR congress in Vienna, examined the links between osteoarthritis and 61 different comorbidities identified before and after the initial osteoarthritis diagnosis. Consistency across the four countries was confirmed when results from all centers were significant and aligned in one direction.

Across the four databases, there were 845,373 cases of osteoarthritis and 2,556,243 controls. Pooled prevalence data revealed several conditions more common in individuals with osteoarthritis compared to matched controls. The most prevalent conditions were chronic back pain, hypertension, allergies, cataracts, vertigo, depression, and diabetes. Of the 33 comorbidities studied, 10, including fibromyalgia, polymyalgia, and chronic back pain, showed consistent evidence of association with osteoarthritis during diagnosis across the four countries. The three major comorbidities that developed after the osteoarthritis diagnosis were fibromyalgia, rheumatoid arthritis, and polymyalgia. No consistent association before or after the diagnosis of osteoarthritis was found for 14 chronic conditions, including heart failure, diabetes, dementia, and chronic obstructive pulmonary disease.

These findings are crucial for planning the management of osteoarthritis patients and suggest the need for further research to establish the causal relationships between osteoarthritis and its comorbidities.


New findings highlight the benefits of Cimzia for women with chronic rheumatic conditions during pregnancy and post-partum, as well as for individuals with RA and elevated rheumatoid factor levels

Data from three separate studies affirm the advantages of Cimzia (certolizumab pegol), a PEGylated fragment crystalized (Fc)-free TNFi, for women of childbearing age with chronic immune-mediated diseases and for those with rheumatoid arthritis (RA) with high rheumatoid factor (RF) levels.

CHERISH Study Outcomes

Results from the CHERISH study, an open-label, phase 1b trial involving women with immune-mediated diseases like psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and rheumatoid arthritis, indicated that blood plasma concentrations of certolizumab pegol during and after pregnancy were comparable to those in non-pregnant women with these conditions. This suggests that therapeutic levels of certolizumab pegol can be maintained throughout pregnancy and post-partum. While plasma levels were lower during pregnancy than post-partum, they remained stable throughout pregnancy.

These findings expand on existing evidence regarding the use of certolizumab pegol in women of childbearing age with chronic immune-mediated diseases. Previous studies, CRIB and CRADLE, demonstrated minimal to no transfer of the drug from mother to baby via the placenta or breast milk. The CHERISH study further explores the stability of certolizumab pegol exposure for the mother. The safety profile observed was consistent with known data on certolizumab pegol, which includes extensive pharmacovigilance information.

RF-Drug Interaction Study

Another study presented at EULAR offered molecular insights into why individuals with RA and high RF levels maintain stable drug concentrations and clinical outcomes when treated with certolizumab pegol compared to Fc-containing TNFis. An in vitro study revealed that three different RF antibodies bound to the Fc-containing TNFi adalimumab, facilitating the formation of large immune complexes. In contrast, RFs did not interact with certolizumab pegol due to its lack of an Fc domain, preventing complex formation with RF.

REALISTIC Trial Outcomes

Additional insights into certolizumab pegol's effects in RA patients with high RF levels were provided by a post hoc analysis of the double-blind, placebo-controlled, phase 3b REALISTIC trial, also presented at EULAR. The clinical response to certolizumab pegol was evaluated in patients with the highest quartile RF levels compared to the lowest, and in those with a previous inadequate response to TNFis versus no prior TNFi exposure. Certolizumab pegol showed better responses than placebo in all groups.

Among patients with previous inadequate TNFi responses, those on placebo had lower responses in the high RF group compared to the low RF group. However, clinical responses to certolizumab pegol were similar regardless of RF level, indicating that RF levels do not affect patient response to certolizumab pegol.


UCB Presents Groundbreaking Two-Year Data on Bimzelx in Patients with Axial Spondyloarthritis and Psoriatic Arthritis

UCB presented two-year data from studies on BIMZELX (bimekizumab) in treating axial spondyloarthritis and psoriatic arthritis.

Key Findings in Axial Spondyloarthritis (axSpA)

Patients with both non-radiographic (nr-axSpA) and radiographic axSpA (r-axSpA) treated with bimekizumab demonstrated remarkable clinical improvements and patient-reported outcomes over a two-year period. Late-breaking data revealed that more than 90% of r-axSpA patients on bimekizumab experienced no spinal radiographic progression, as indicated by a modified Stoke Ankylosing Spondylitis Spinal Score change from baseline of less than 2.

Key Findings in Psoriatic Arthritis (PsA)

For patients with psoriatic arthritis, including those new to biologics and those previously unresponsive or intolerant to tumor necrosis factor inhibitors, bimekizumab treatment led to sustained minimal disease activity for up to two years.

Study Highlights

  • ASAS40 Achievement: At the 104-week mark, 49.2% of patients with non-radiographic axial spondyloarthritis (nr-axSpA)and 53.9% of those with radiographic axSpA (r-axSpA)treated with bimekizumab reached the ASAS40 criteria

  • Low Disease Activity: By Week 104, 61.2% of nr-axSpA patients and 63.4% of r-axSpA patients (n=332) on bimekizumab achieved low disease activity, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 2.1.

  • Inactive Disease Status: At the same time point, 31.6% of nr-axSpA patients and 31.3% of r-axSpA patients reached a state of inactive disease, with an ASDAS score of less than 1.3.

  • AxSpA Outcomes: Data from the BE MOBILE 1, BE MOBILE 2, and BE MOVING studies showed that about half of the patients treated with bimekizumab achieved a 40% or greater improvement in axSpA symptoms. Additionally, around 60% reached low disease activity (ASDAS <2.1), and approximately 30% achieved inactive disease (ASDAS <1.3).

  • Radiographic Progression: Over two years, the majority of r-axSpA patients had minimal spinal radiographic progression, with 85.3% showing no progression (mSASSS change from baseline ≤0.5) and 92.1% having an mSASSS change from baseline <2, even among those with baseline spinal damage.

  • MRI and Tissue Repair: One-year results indicated significant improvements in MRI-detected inflammation and reductions in erosions, suggesting potential tissue repair in the sacroiliac joints of axSpA patients.

  • Patient-Reported Outcomes: Patients consistently reported sustained improvements in spinal pain, morning stiffness, and fatigue over two years.

  • Safety Profile: The safety profile of bimekizumab was consistent with previous studies, showing no new safety signals. The most frequent adverse events included COVID-19, nasopharyngitis, and upper respiratory tract infections.

Psoriatic Arthritis Data

  • Minimal Disease Activity: In the BE OPTIMAL and BE COMPLETE studies, approximately 52.4% of biologic-naïve PsA patients and 49.8% of those who switched from placebo achieved minimal disease activity by week 104. Among PsA patients with inadequate response to TNF inhibitors, 46.1% achieved minimal disease activity by week 88.

  • Remission Rates: Trends showed similar success in achieving DAPSA remission and low disease activity by week 104/88.

These findings from UCB highlight the potential of bimekizumab as a groundbreaking treatment option for patients with axSpA and PsA, offering sustained relief and improved quality of life over the long term. The presentation of this data at EULAR 2024 marks a significant milestone in the management of these chronic conditions.


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