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All Journal Jurnal Penyakit Dalam Indonesia Indonesian Journal of Biomedicine and Clinical Sciences
Setyobudi, Assyadilla Kirana
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Biochemistry, Genetics & Molecular Biology Health Professions Immunology & microbiology Medicine & Pharmacology Neuroscience

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Safety and efficacy of ontamalimab in inflammatory bowel disease: A systematic review and dose- response meta-analysis Setyobudi, Assyadilla Kirana; Yudianto, Valentino Ryu; Hariftyani, Arisvia Sukma; Gatot Soegiarto
Indonesian Journal of Biomedicine and Clinical Sciences Vol 57 No 4 (2025)
Publisher : Published by Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/inajbcs.v57i4.20500

Abstract

Inflammatory bowel diseases (IBDs), such as Crohn’s disease and ulcerative colitis, involve chronic inflammation of the digestive tract. The incidence of IBD has been increasing globally, posing a growing burden despite advancements in treatment. Novel therapies targeting adhesion molecules such as MAdCAM-1 show promise by specifically inhibiting lymphocyte infiltration into the gut, potentially offering safer and more effective treatment options. This meta-analysis and systematic review were conducted to provide efficacy and safety analysis of ontamalimab for IBD treatment. Dose-response (DRMA), network (NMA), and random effect meta-analysis were conducted to extract clinical response, clinical remission, biomarker change, and adverse events of ontamalimab. Studies were retrieved from PubMed, Cochrane, and EMBASE to describe the pooled risk ratio (RR) and heterogeneity was determined if I2 >50%. RoB2 tool and ROBINS-I were used to assess risk of bias in RCT and clinical trial studies, respectively. The result was considered significant if p<0.05. A total of 670 studies were screened, resulting in 8 multicentre studies. There were significant differences in clinical response (RR: 1.39; 95%CI: 1.12–1.73; p = 0.003; I2= 35%), clinical remission (RR: 1.72; 95%CI: 1.17–2.53; p=0.006; I2= 26%), mean change of FC (RR: 624.29; 95%CI: 543.28-705.29; p<0.001; I2= 0%), mean change of CRP serum (RR: 9.71; 95%CI: 7.12–12.3; p<0.001), and mean MAdCAM-1 serum level (RR: 235.57; 95%CI: 203.80–267.33; p <0.001) between ontamalimab 75 mg and placebo after 12 wk of treatment. Meanwhile, adverse events from both groups were similar to those observed in patients treated with either placebo or ontamalimab. This study concluded that ontamalimab 75mg demonstrated significant efficacy in treating IBD, achieving superior outcomes in clinical response and clinical remission compared to placebo. Importantly, no cases of PML and significant adverse events were detected, indicating a favorable safety profile relative to other anti-MAdCAM-1 therapies.
Safety and efficacy of ontamalimab in inflammatory bowel disease: A systematic review and dose- response meta-analysis Setyobudi, Assyadilla Kirana; Yudianto, Valentino Ryu; Hariftyani, Arisvia Sukma; Gatot Soegiarto
Indonesian Journal of Biomedicine and Clinical Sciences Vol 57 No 4 (2025)
Publisher : Published by Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/inajbcs.v57i4.20500

Abstract

Inflammatory bowel diseases (IBDs), such as Crohn’s disease and ulcerative colitis, involve chronic inflammation of the digestive tract. The incidence of IBD has been increasing globally, posing a growing burden despite advancements in treatment. Novel therapies targeting adhesion molecules such as MAdCAM-1 show promise by specifically inhibiting lymphocyte infiltration into the gut, potentially offering safer and more effective treatment options. This meta-analysis and systematic review were conducted to provide efficacy and safety analysis of ontamalimab for IBD treatment. Dose-response (DRMA), network (NMA), and random effect meta-analysis were conducted to extract clinical response, clinical remission, biomarker change, and adverse events of ontamalimab. Studies were retrieved from PubMed, Cochrane, and EMBASE to describe the pooled risk ratio (RR) and heterogeneity was determined if I2 >50%. RoB2 tool and ROBINS-I were used to assess risk of bias in RCT and clinical trial studies, respectively. The result was considered significant if p<0.05. A total of 670 studies were screened, resulting in 8 multicentre studies. There were significant differences in clinical response (RR: 1.39; 95%CI: 1.12–1.73; p = 0.003; I2= 35%), clinical remission (RR: 1.72; 95%CI: 1.17–2.53; p=0.006; I2= 26%), mean change of FC (RR: 624.29; 95%CI: 543.28-705.29; p<0.001; I2= 0%), mean change of CRP serum (RR: 9.71; 95%CI: 7.12–12.3; p<0.001), and mean MAdCAM-1 serum level (RR: 235.57; 95%CI: 203.80–267.33; p <0.001) between ontamalimab 75 mg and placebo after 12 wk of treatment. Meanwhile, adverse events from both groups were similar to those observed in patients treated with either placebo or ontamalimab. This study concluded that ontamalimab 75mg demonstrated significant efficacy in treating IBD, achieving superior outcomes in clinical response and clinical remission compared to placebo. Importantly, no cases of PML and significant adverse events were detected, indicating a favorable safety profile relative to other anti-MAdCAM-1 therapies.
Faktor Risiko Perdarahan Gastrointestinal pada Pasien dengan Sindrom Koroner Akut: Sebuah Tinjauan Sistematis setyobudi, Assyadilla Kirana; Vidyani, Amie; Sutadji, Jonathan Christianto; Kurniawati, Lady Aqnes; Suhardi, Kevin Fernando
Jurnal Penyakit Dalam Indonesia Vol. 13, No. 1
Publisher : UI Scholars Hub

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

Introduction. Gastrointestinal bleeding (GIB) is a serious but potentially preventable condition. Its symptoms include hematemesis, hematochezia, and melena. Risk factors for GIB include medications such as antiplatelets and anticoagulants, which are standard treatments for acute coronary syndrome (ACS). GIB is strongly associated with ACS and represents the most common bleeding complication in these patients. This study aimed to systematically review the factors contributing to GIB in patients with ACS. Methods. Relevant articles were retrieved from PubMed, ScienceDirect, Springer, and EBSCO databases, covering studies on GIB risk factors in ACS patients published between March 31, 2003, and March 31, 2025. The search was conducted using specific keywords and Boolean operators. Data were then extracted and comprehensively evaluated. Results. A total of 17 studies were included, with varied patient populations, including general ACS patients, as well as those specifically diagnosed with acute myocardial infarction (AMI), ST-elevation myocardial infarction (STEMI), or non-ST-elevation myocardial infarction (NSTEMI). The follow-up periods ranged widely, from 15 days to 4 years. Based on the initial evaluation, 23 potential risk factors were identified. GIB was more likely to occur in older individuals, females, and those with a history of smoking and alcohol consumption. Comorbidities, including anemia, diabetes, peptic ulcer disease, cirrhosis, and chronic kidney disease, were also more frequently observed among ACS patients with GIB events. The use of proton pump inhibitors (PPIs) was identified as the only protective factor. Conclusion. This systematic review identified several risk factors associated with GIB in ACS patients. Careful monitoring and appropriate management should be implemented in patients with these risk factors to prevent bleeding events, which may be fatal.
Co-Authors Amie Vidyani Gatot Soegiarto Hariftyani, Arisvia Sukma Kurniawati, Lady Aqnes Suhardi, Kevin Fernando Sutadji, Jonathan Christianto Yudianto, Valentino Ryu