Related Experiment Video
Updated: Dec 20, 2025
04:41
Knee Arthrocentesis in Adults
Published on: February 25, 2022
8.9K
Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials
Vineet S Rolston1, Jessica Kimmel1, Violeta Popov1,2
1Division of Gastroenterology, NYU School of Medicine, New York, NY, USA.
Digestive Diseases and Sciences
|May 24, 2020
Summary
Ustekinumab (UST) did not show increased short-term adverse events compared to placebo in randomized trials for autoimmune conditions. This meta-analysis included 30 trials, finding no significant differences in mild or serious side effects.
Area of Science:
- Immunology
- Gastroenterology
- Clinical Trials
Background:
- Ustekinumab (UST) is an IL-12/IL-23 inhibitor used for Crohn's disease and ulcerative colitis.
- Evaluating adverse events (AEs) of UST across indications is crucial for patient safety.
Purpose of the Study:
- To perform a meta-analysis comparing AE rates in randomized controlled trials (RCTs) of UST.
- To assess the short-term safety profile of UST versus placebo and other biologics.
Main Methods:
- Systematic search of MEDLINE, Embase, and PubMed databases up to November 2019.
- Inclusion of 30 RCTs involving 16,068 patients (≥18 years) with autoimmune conditions.
- Meta-analysis focused on UST versus placebo, including a sub-analysis for Crohn's disease and ulcerative colitis.
Main Results:
- No significant difference in serious AEs (OR 0.83) or mild/moderate AEs (OR 1.08) between UST and placebo over 16 weeks.
- Sub-analysis of Crohn's disease and ulcerative colitis trials showed similar AE rates for UST versus placebo.
- Total analysis included 9,626 subjects in the UST vs. placebo comparison.
Conclusions:
- Ustekinumab (UST) is not associated with an increased short-term risk of adverse events.
- The safety profile of UST appears favorable in the short term across various autoimmune indications.
Related Concept Videos
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
323
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
323
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
374
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
374
01:29Therapeutic Drug Monitoring: Affecting Factors
126
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
126
01:25Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs
1.6K
Asthma is a chronic respiratory condition for which new therapeutic avenues, including anti-inflammatory drugs like mast cell stabilizers and anti-IgE treatments, continue to be developed.
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
1.6K
01:11Blinding
3.7K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
3.7K
01:13Therapeutic Index
6.3K
The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...
6.3K