Related Experiment Video
Updated: Oct 4, 2025
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
17.9K
Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD
Geert R D'Haens1, William J Sandborn2, Edward V Loftus3
1Amsterdam Gastroenterology Endocrinology Metabolism and Gastroenterology and Hepatology Departments, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Gastroenterology
|February 5, 2022
Summary
Higher induction dosing of adalimumab did not improve clinical remission or endoscopic response in Crohn's disease patients. Both clinically adjusted and therapeutic drug monitoring maintenance strategies showed similar efficacy for adalimumab therapy.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Dose optimization for biologic therapies in Crohn's disease (CD) remains an area needing established strategies.
- The SERENE CD trial investigated novel dosing approaches for adalimumab in moderate to severe CD.
Purpose of the Study:
- To evaluate higher versus standard induction dosing of adalimumab in CD patients.
- To compare clinically adjusted (CA) versus therapeutic drug monitoring (TDM) maintenance strategies for adalimumab therapy.
Main Methods:
- Phase 3, randomized, double-blind, multicenter trial involving adult patients with active CD.
- Patients received higher or standard adalimumab induction, followed by maintenance therapy stratified by CA or TDM.
- Co-primary endpoints included clinical remission at week 4 and endoscopic response at week 12.
Main Results:
- Higher induction dosing was not superior to standard induction regarding clinical remission (44% vs 44%) or endoscopic response (43% vs 39%).
- Maintenance strategies (CA vs TDM) demonstrated similar efficacy at week 56.
- Adalimumab therapy exhibited comparable safety profiles across all dosing regimens.
Conclusions:
- Higher induction dosing of adalimumab offers no significant advantage over standard induction for moderate to severe Crohn's disease.
- Both CA and TDM maintenance strategies are equally effective for adalimumab therapy in CD.
- Adalimumab treatment was well-tolerated with no new safety concerns identified.
More Related Videos
Related Concept Videos
01:24Rational Dosage Regimen: Maintenance Dose and Loading Dose
4.6K
A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
4.6K
01:15Drug Dosage Regimen: Overview
3.9K
A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
3.9K
01:28Dosage Regimens: Designs and Approaches
10
Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
10
01:25Determination of Multiple Dosing Parameters: Loading and Maintenance Doses
11
A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...
11
01:01Dosage Regimen: Fixed Dose
2.0K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
2.0K
01:24Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
8
Intermittent intravenous (IV) infusion is a method of drug administration where medications are delivered over short infusion periods followed by intervals of no drug delivery. This approach helps to prevent sustained high drug concentrations in the bloodstream, reducing the risk of adverse effects associated with prolonged exposure. Unlike continuous infusion, steady-state concentrations may not be achieved during a single dosing cycle but can be reached through repeated...
8