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Systemic Inflammatory Immune Index (SII) Predicts Disease Activity in Systemic Lupus Erythematosus (SLE) Patients: A Cross-Sectional Study Susanto, Edi; Yuniza; Legiran; Nova Kurniati; Eddy Mart Salim
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 4 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i4.1237

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by widespread inflammation and diverse clinical manifestations. The systemic inflammatory immune index (SII), calculated as platelet count * neutrophil count/lymphocyte count, has emerged as a potential marker of systemic inflammation in various conditions. This study aimed to investigate the relationship between SII and disease activity in SLE patients. Methods: We conducted a cross-sectional study involving 60 SLE patients diagnosed according to the 2019 EULAR/ACR classification criteria. Demographic and clinical data were collected, and disease activity was assessed using the Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX-SLEDAI). Blood samples were analyzed to determine SII values. Statistical analysis included Spearman's correlation to assess the relationship between SII and MEX-SLEDAI scores. Results: The study population predominantly consisted of women (98.3%), with a median age of 29 years. A strong positive correlation was observed between SII and MEX-SLEDAI scores (r = 0.931, p < 0.001). Patients with higher SII values exhibited significantly greater disease activity. Conclusion: Our findings suggest that SII is a promising predictor of disease activity in SLE patients. This readily available index may aid clinicians in assessing disease severity and tailoring treatment strategies. Further research is warranted to validate these findings and explore the utility of SII in monitoring disease progression and treatment response.

Cardiac Myosin Inhibitors in Hypertrophic Cardiomyopathy: A Head-to-Head Network Meta-Analysis of Mavacamten and Aficamten Imran Saleh; Syamsu Indra; Yenny Dian Andayani; Rukiah Chodilawati; Yuniza
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 8 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i8.1360

Background: Hypertrophic cardiomyopathy (HCM) is a genetic disorder characterized by myocardial hypercontractility. Mavacamten and aficamten are first-in-class cardiac myosin inhibitors that have demonstrated efficacy in treating obstructive HCM. However, in the absence of direct head-to-head randomized controlled trials (RCTs), their comparative effectiveness and safety remain unquantified. We aimed to indirectly compare the efficacy and safety of mavacamten and aficamten in patients with obstructive HCM. Methods: We conducted a systematic review and Bayesian network meta-analysis of RCTs. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to December 2024. Eligible studies were RCTs comparing mavacamten or aficamten with placebo in adults with obstructive HCM. The primary efficacy outcomes were the change from baseline in post-exercise left ventricular outflow tract (LVOT) gradient and the change in peak oxygen consumption (pVO₂). The primary safety outcome was the incidence of left ventricular ejection fraction (LVEF) reduction to <50%. Results: Seven RCTs involving 1,025 patients were included. In the network meta-analysis, both aficamten (Mean Difference [MD], -50.8 mmHg; 95% Credible Interval [CrI], -61.2 to -40.4) and mavacamten (MD, -44.9 mmHg; 95% CrI, -53.7 to -36.1) were significantly more effective than placebo in reducing post-exercise LVOT gradient. The indirect comparison between the two agents did not reveal a statistically significant difference (MD, -5.9 mmHg; 95% CrI, -17.8 to 6.0). For pVO₂, both mavacamten and aficamten showed significant improvement over placebo, with no significant difference between them. The odds of LVEF dropping below 50% were numerically higher with mavacamten compared to aficamten, but the difference was not statistically significant (Odds Ratio [OR], 1.52; 95% CrI, 0.65 to 3.54). Conclusion: Mavacamten and aficamten are both highly effective in improving hemodynamic and functional parameters in patients with obstructive HCM. While our indirect comparison did not establish the superiority of one agent over the other, it provides foundational evidence for clinicians. Definitive conclusions await direct head-to-head clinical trials.

Cardiac Myosin Inhibitors in Hypertrophic Cardiomyopathy: A Head-to-Head Network Meta-Analysis of Mavacamten and Aficamten Imran Saleh; Syamsu Indra; Yenny Dian Andayani; Rukiah Chodilawati; Yuniza
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 8 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i8.1360

Background: Hypertrophic cardiomyopathy (HCM) is a genetic disorder characterized by myocardial hypercontractility. Mavacamten and aficamten are first-in-class cardiac myosin inhibitors that have demonstrated efficacy in treating obstructive HCM. However, in the absence of direct head-to-head randomized controlled trials (RCTs), their comparative effectiveness and safety remain unquantified. We aimed to indirectly compare the efficacy and safety of mavacamten and aficamten in patients with obstructive HCM. Methods: We conducted a systematic review and Bayesian network meta-analysis of RCTs. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to December 2024. Eligible studies were RCTs comparing mavacamten or aficamten with placebo in adults with obstructive HCM. The primary efficacy outcomes were the change from baseline in post-exercise left ventricular outflow tract (LVOT) gradient and the change in peak oxygen consumption (pVO₂). The primary safety outcome was the incidence of left ventricular ejection fraction (LVEF) reduction to <50%. Results: Seven RCTs involving 1,025 patients were included. In the network meta-analysis, both aficamten (Mean Difference [MD], -50.8 mmHg; 95% Credible Interval [CrI], -61.2 to -40.4) and mavacamten (MD, -44.9 mmHg; 95% CrI, -53.7 to -36.1) were significantly more effective than placebo in reducing post-exercise LVOT gradient. The indirect comparison between the two agents did not reveal a statistically significant difference (MD, -5.9 mmHg; 95% CrI, -17.8 to 6.0). For pVO₂, both mavacamten and aficamten showed significant improvement over placebo, with no significant difference between them. The odds of LVEF dropping below 50% were numerically higher with mavacamten compared to aficamten, but the difference was not statistically significant (Odds Ratio [OR], 1.52; 95% CrI, 0.65 to 3.54). Conclusion: Mavacamten and aficamten are both highly effective in improving hemodynamic and functional parameters in patients with obstructive HCM. While our indirect comparison did not establish the superiority of one agent over the other, it provides foundational evidence for clinicians. Definitive conclusions await direct head-to-head clinical trials.

Prototype Saudagar Muslim Etika Pelaku Bisnis Islami dalam Praktik Kewirausahaan Farmasi Apotek Lugina Rancaekek M. Furqon Baihaqi; Riska Auliandini; Yuniza; Mochamad Fadlani Salam
Jejak digital: Jurnal Ilmiah Multidisiplin Vol. 1 No. 4 (2025): JULI (Edisi Spesial)
Publisher : INDO PUBLISHING

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.63822/cj38vm37

Praktik kewirausahaan farmasi tidak hanya menuntut efisiensi dan profitabilitas, tetapi juga kepatuhan terhadap etika bisnis, khususnya dalam konteks nilai-nilai Islam. Penelitian ini bertujuan untuk mengkaji implementasi etika bisnis Islami dalam pengelolaan Apotek Lugina di Kecamatan Rancaekek, dengan menyoroti aspek pengambilan keuntungan, transparansi harga, dan pelayanan pasien. Metode yang digunakan adalah deskriptif kualitatif dengan pendekatan studi kasus melalui observasi, wawancara, dokumentasi, dan kajian literatur. Hasil penelitian menunjukkan bahwa Apotek Lugina mengintegrasikan prinsip shiddiq (jujur), amanah (dapat dipercaya), tabligh (menyampaikan kebenaran), dan fathonah (cerdas) dalam pelayanan kefarmasian. Praktik harga sesuai dengan Harga Eceran Tertinggi (HET), edukasi pasien diterapkan secara beretika, dan nilai 5S (senyum, sapa, salam, sopan, santun) menjadi budaya pelayanan utama. Temuan ini memperkuat bahwa etika bisnis Islami mampu meningkatkan kepercayaan dan loyalitas konsumen serta menjadi strategi unggulan dalam menghadapi persaingan industri farmasi. Studi ini merekomendasikan penguatan pendidikan kewirausahaan Islami bagi tenaga kefarmasian sebagai upaya membentuk karakter saudagar Muslim modern yang profesional, spiritual, dan berorientasi maslahat.

Efficacy and Safety of IL-5 Pathway-Targeting Biologics (Mepolizumab, Reslizumab, Benralizumab) in the Management of Hypereosinophilic Syndromes: A Systematic Review and Meta-Analysis Yuniza; Melani; Ratna Maila Dewi Anggraini; Yenny Dian Andayani
Open Access Indonesian Journal of Medical Reviews Vol. 5 No. 5 (2025): Open Access Indonesian Journal of Medical Reviews
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/oaijmr.v5i5.780

Hypereosinophilic syndromes (HES) are rare disorders defined by persistent eosinophilia and eosinophil-driven organ damage. Interleukin-5 (IL-5) is the central cytokine governing eosinophil maturation and survival, establishing its pathway as a critical therapeutic target. While individual trials of biologics targeting the IL-5 pathway—mepolizumab, reslizumab, and benralizumab—have shown promise, a quantitative synthesis of their class-wide efficacy and safety in HES is needed. This study aimed to meta-analyze the evidence for these agents in managing HES. Following PRISMA guidelines, we systematically searched PubMed, Embase, and Cochrane Library through December 2024 for randomized controlled trials (RCTs) and prospective observational studies of IL-5 pathway biologics in patients with HES. Primary outcomes were the proportion of patients achieving hematologic response and the annualized rate of clinical exacerbations. Key secondary outcomes included oral corticosteroid (OCS) dose reduction and adverse events (AEs). Data were pooled using a random-effects model, with extensive, pre-planned subgroup and sensitivity analyses to explore heterogeneity. Seven studies (3 RCTs, 4 observational) involving 388 patients were included. Patients receiving IL-5 pathway biologics had significantly higher odds of achieving hematologic response (Odds Ratio [OR] 9.85; 95% Confidence Interval [CI] 5.12-18.96; p<0.0001), a finding robust to sensitivity analyses of different response definitions. The annualized exacerbation rate was reduced by 64% (Rate Ratio 0.36; 95% CI 0.25-0.52; p<0.0001). The intervention led to a mean daily OCS reduction of 12.5 mg (95% CI -15.8 to -9.2 mg; p<0.0001). Subgroup analysis revealed this effect was more pronounced in observational studies than in RCTs. The overall risk of AEs was not significantly increased. This meta-analysis provides robust evidence that biologics targeting the IL-5 pathway are highly effective and generally safe for managing PDGFRA-negative HES. They induce high rates of hematologic remission, substantially reduce clinical exacerbations, and facilitate a significant corticosteroid-sparing effect. These findings strongly support their role as a foundational component of modern HES therapy, though long-term safety and efficacy within distinct HES subtypes warrant further investigation.

The Paradoxical Role of Interleukin-10 in Systemic Lupus Erythematosus: A Correlational Study of Serum Levels and Disease Activity Yuniza; Joneri, Alrahman; Legiran; Nova Kurniati; Eddy Mart Salim
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 12 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i12.1452

Background: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease where the cytokine Interleukin-10 (IL-10) exhibits a paradoxical role, functioning as both a potent anti-inflammatory mediator and a robust B-cell stimulator. The clinical significance of serum IL-10 as a biomarker of disease activity is a subject of intense debate, with conflicting reports in the literature. This study was designed to investigate this relationship within a specific Southeast Asian cohort. Methods: An observational, cross-sectional study was conducted at a tertiary referral hospital in Palembang, Indonesia, enrolling 48 adult patients with a confirmed diagnosis of SLE. Disease activity was quantitatively scored using the Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX-SLEDAI). Serum IL-10 concentrations were precisely measured using a quantitative sandwich enzyme-linked immunosorbent assay (ELISA). The primary statistical analysis involved the Spearman rank correlation test. A post-hoc power analysis was performed to contextualize the statistical findings. Results: The study population was predominantly female (95.8%), with the largest subgroup (54.2%) presenting with mild disease activity. The mean serum IL-10 concentration was 9.91±1.36 pg/mL in the mild activity group, rose to a peak of 12.22±1.95 pg/mL in the moderate activity group, and was 10.65±2.34 pg/mL in the severe activity group. The Spearman correlation test identified a weak, positive association that did not achieve statistical significance (r=0.274, p=0.059). The post-hoc power analysis confirmed the study was underpowered to definitively detect a correlation of this magnitude. Conclusion: In this cohort of Indonesian SLE patients, a statistically significant correlation between serum IL-10 levels and disease activity was not established. Given the study's methodological context, including its cross-sectional design and limited statistical power, the findings are inconclusive but hypothesis-generating. The results reinforce the profound complexity of IL-10 biology in SLE and underscore the challenges in validating it as a standalone biomarker, highlighting the need for larger, longitudinal investigations.

The Paradoxical Role of Interleukin-10 in Systemic Lupus Erythematosus: A Correlational Study of Serum Levels and Disease Activity Yuniza; Joneri, Alrahman; Legiran; Nova Kurniati; Eddy Mart Salim
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 12 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i12.1452

Background: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease where the cytokine Interleukin-10 (IL-10) exhibits a paradoxical role, functioning as both a potent anti-inflammatory mediator and a robust B-cell stimulator. The clinical significance of serum IL-10 as a biomarker of disease activity is a subject of intense debate, with conflicting reports in the literature. This study was designed to investigate this relationship within a specific Southeast Asian cohort. Methods: An observational, cross-sectional study was conducted at a tertiary referral hospital in Palembang, Indonesia, enrolling 48 adult patients with a confirmed diagnosis of SLE. Disease activity was quantitatively scored using the Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX-SLEDAI). Serum IL-10 concentrations were precisely measured using a quantitative sandwich enzyme-linked immunosorbent assay (ELISA). The primary statistical analysis involved the Spearman rank correlation test. A post-hoc power analysis was performed to contextualize the statistical findings. Results: The study population was predominantly female (95.8%), with the largest subgroup (54.2%) presenting with mild disease activity. The mean serum IL-10 concentration was 9.91±1.36 pg/mL in the mild activity group, rose to a peak of 12.22±1.95 pg/mL in the moderate activity group, and was 10.65±2.34 pg/mL in the severe activity group. The Spearman correlation test identified a weak, positive association that did not achieve statistical significance (r=0.274, p=0.059). The post-hoc power analysis confirmed the study was underpowered to definitively detect a correlation of this magnitude. Conclusion: In this cohort of Indonesian SLE patients, a statistically significant correlation between serum IL-10 levels and disease activity was not established. Given the study's methodological context, including its cross-sectional design and limited statistical power, the findings are inconclusive but hypothesis-generating. The results reinforce the profound complexity of IL-10 biology in SLE and underscore the challenges in validating it as a standalone biomarker, highlighting the need for larger, longitudinal investigations.

Systemic Inflammatory Immune Index (SII) Predicts Disease Activity in Systemic Lupus Erythematosus (SLE) Patients: A Cross-Sectional Study Susanto, Edi; Yuniza; Legiran; Nova Kurniati; Eddy Mart Salim
Bioscientia Medicina : Journal of Biomedicine and Translational Research Vol. 9 No. 4 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research
Publisher : HM Publisher

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.37275/bsm.v9i4.1237

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by widespread inflammation and diverse clinical manifestations. The systemic inflammatory immune index (SII), calculated as platelet count * neutrophil count/lymphocyte count, has emerged as a potential marker of systemic inflammation in various conditions. This study aimed to investigate the relationship between SII and disease activity in SLE patients. Methods: We conducted a cross-sectional study involving 60 SLE patients diagnosed according to the 2019 EULAR/ACR classification criteria. Demographic and clinical data were collected, and disease activity was assessed using the Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX-SLEDAI). Blood samples were analyzed to determine SII values. Statistical analysis included Spearman's correlation to assess the relationship between SII and MEX-SLEDAI scores. Results: The study population predominantly consisted of women (98.3%), with a median age of 29 years. A strong positive correlation was observed between SII and MEX-SLEDAI scores (r = 0.931, p < 0.001). Patients with higher SII values exhibited significantly greater disease activity. Conclusion: Our findings suggest that SII is a promising predictor of disease activity in SLE patients. This readily available index may aid clinicians in assessing disease severity and tailoring treatment strategies. Further research is warranted to validate these findings and explore the utility of SII in monitoring disease progression and treatment response.

Correlation of TNF-α with Systemic Lupus Erythematosus Activity in Mohammad Hoesin Hospital Palembang Ismed, Yonis; Kurniati, Nova; Theodorus; Yuniza; Salim, Eddy Mart
Sriwijaya Journal of Medicine Vol. 8 No. 3 (2025): Vol 8, No 3, 2025 (Issue In Progress)
Publisher : Fakultas Kedokteran Universitas Sriwijaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.32539/sjm.v8i3.349

Systemic lupus erythematosus (SLE) is a persistent autoimmune disorder marked by immunological dysregulation and widespread inflammation. Tumor necrosis factor-α (TNF-α), a pivotal pro-inflammatory cytokine, has been associated with the pathophysiology of systemic lupus erythematosus (SLE), although its clinical relevance is still debated. This study aims to assess the connection between serum TNF-α levels and disease activity, as quantified by the Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX-SLEDAI), in Indonesian patients with systemic lupus erythematosus (SLE). A cross-sectional study was performed including 34 patients exhibiting mild-to-moderate systemic lupus erythematosus activity (MEX-SLEDAI ≤12) at Dr. Mohammad Hoesin General Hospital in Palembang, Indonesia. Individuals with significant active disease were excluded. Serum TNF-α concentrations were quantified via a commercial ELISA kit, while disease activity was evaluated through MEX-SLEDAI. Correlation analysis was conducted using Spearman’s rank test, with p < 0.05 being statistically significant. The average age of participants was 33.6 ± 11.0 years, with 94.1% identifying as female. The median MEX-SLEDAI score was 3 (range 2–7), and the median TNF-α level was 1.834 pg/mL (range 0.99–8.62). No substantial connection was detected between serum TNF-α levels and disease activity (r = 0.111, p = 0.533). This suggests that serum TNF-α levels did not correlate with or forecast clinical disease activity in this investigation. The results indicate that the efficacy of TNF-α as a biomarker in SLE may be contingent upon contextual factors, especially illness severity. Additional multicenter and longitudinal studies involving individuals with a broader spectrum of disease activity are necessary to elucidate its clinical significance.

Correlation Between Serum Malondialdehyde Levels and Disease Activity in Patients with Mild to Moderate Systemic Lupus Erythematosus Hartanto, Kristian; Kurniati, Nova; Theodorus; Yuniza; Salim, Eddy Mart
Sriwijaya Journal of Medicine Vol. 8 No. 3 (2025): Vol 8, No 3, 2025 (Issue In Progress)
Publisher : Fakultas Kedokteran Universitas Sriwijaya

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.32539/sjm.v8i3.350

Systemic lupus erythematosus (SLE) is characterized by persistent inflammation and oxidative stress, which contribute to the progression of the disease. Lipid peroxidation is indicated by malondialdehyde (MDA). The objective of this investigation was to evaluate the correlation between serum MDA levels and disease activity in patients with mild to moderate systemic lupus erythematosus (SLE). This investigation was a cross-sectional correlation analysis that employed baseline data from adult patients with systemic lupus erythematosus who were receiving conventional treatment. Spearman's correlation was employed to determine the relationship between serum MDA levels and disease activity, which was evaluated using the MEX-SLEDAI score. The study encompassed 38 patients with mild to moderate SLE. The MEX-SLEDAI score was 3 (range 2–7), and the median serum MDA concentration was 1.42 µmol/L (range 0.90–1.99). Spearman's correlation analysis demonstrated a moderately positive correlation between serum MDA levels and MEX-SLEDAI scores (r = 0.415, p = 0.010), indicating that elevated oxidative stress is associated with increased disease activity in SLE patients. A considerable positive correlation between serum malondialdehyde levels and disease activity is statistically significant in patients with mild to moderate systemic lupus erythematosus (SLE). These results support the existence of oxidative stress in the pathophysiology of lupus and suggest that MDA may serve as a potential biomarker for disease monitoring.

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