Interferon beta-1b in treatment-naïve paediatric patients with relapsing-remitting multiple sclerosis: Two-year

Jutta Gärtner1, Wolfgang Brück2, Almuth Weddige1

  • 1Department of Paediatrics and Adolescent Medicine, University Medical Center Göttingen, Germany.

Insights

Interferon beta-1b (IFNβ-1b) demonstrated a favorable safety profile and effectiveness in treating pediatric patients with relapsing-remitting multiple sclerosis (RRMS). The BETAPAEDIC study found IFNβ-1b to be a well-tolerated treatment option for this young patient population.

Area of Science:

  • Neurology
  • Pediatric Medicine
  • Immunology

Background:

  • Multiple sclerosis (MS) affects children and adolescents, necessitating evaluation of disease-modifying therapies in this demographic.
  • Betaferon (interferon beta-1b) is a treatment for MS, but its safety and efficacy in pediatric patients require specific investigation.

Purpose of the Study:

  • To assess the safety and tolerability of interferon beta-1b (IFNβ-1b) in pediatric patients diagnosed with relapsing-remitting multiple sclerosis (RRMS).
  • To evaluate the effectiveness of IFNβ-1b in managing pediatric RRMS through various clinical and radiological markers.

Main Methods:

  • Prospective, open-label, multicenter observational study (BETAPAEDIC) involving treatment-naïve pediatric patients (12-16 years).
  • Two-year follow-up with visits every six months, assessing annualised relapse rate, Expanded Disability Status Scale (EDSS) progression, MRI, cognitive function, and fatigue.
  • Interferon beta-1b was administered to patients scheduled for treatment initiation.

Main Results:

  • Sixty-seven pediatric patients with RRMS were enrolled. Mean age was 14.2 years.
  • Effectiveness: Mean annualised relapse rate was 0.7; 49.1% were relapse-free, and 76.9% showed no EDSS progression. 41.1% were relapse- and progression-free.
  • Safety: Most frequent adverse events included influenza-like illness, headache, injection-site reactions, and elevated liver enzymes. Fatigue scores remained within normal ranges.

Conclusions:

  • Interferon beta-1b is an effective treatment for pediatric patients with relapsing-remitting multiple sclerosis.
  • The treatment exhibits a favorable safety profile in this young population, with manageable adverse events.
Abstract

Related Concept Videos

Multiple Allele Traits01:49

Multiple Allele Traits

The Concept of Multiple Allelism
38.3K
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
255
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
164
Multiple Regression01:25

Multiple Regression

Multiple regression assesses a linear relationship between one response or dependent variable and two or more independent variables. It has many practical applications.
Farmers can use multiple regression to determine the crop yield based on more than one factor, such as water availability, fertilizer, soil properties, etc. Here, the crop yield is the response or dependent variable as it depends on the other independent variables. The analysis requires the construction of a scatter plot...
4.0K
Multiple Voltage Sources01:25

Multiple Voltage Sources

Generally, a single battery is not enough to power some devices. In such cases, batteries can be combined in two ways: in series or in parallel.
In series, the positive terminal of one battery is connected to the negative terminal of another battery. Hence, the voltage of each battery is added to give the net voltage, which is increased because each battery boosts the electrons that enter it. The same current flows through each battery because they are connected in series.
Batteries are...
1.8K
Deformation of Member under Multiple Loadings01:11

Deformation of Member under Multiple Loadings

When a rod is made of different materials or has various cross-sections, it must be divided into parts that meet the necessary conditions for determining the deformation. These parts are each characterized by their internal force, cross-sectional area, length, and modulus of elasticity. These parameters are then used to compute the deformation of the entire rod.
In the case of a member with a variable cross-section, the strain is not constant but depends on the position. The deformation of an...
497