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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.
Background And Objective:
Study evaluating Betaferon(R)'s safety and tolerability in paediatric patients with multiple sclerosis (BETAPAEDIC) is a prospective, open-label observational multicentre study to assess the safety and effectiveness of interferon beta-1b in paediatric patients with relapsing-remitting multiple sclerosis.
Methods:
Treatment-naïve patients (12-16 years) scheduled to start interferon beta-1b were enrolled with follow-up visits every six months for two years. Effectiveness was evaluated by annualised relapse rate, Expanded Disability Status Scale progression, cranial magnetic resonance imaging and cognitive testing. Fatigue was assessed by the Fatigue Severity Scale.
Results:
Sixty-eight patients were screened and 67 enrolled, with mean (standard deviation) age 14.2 (1.3) years (n=65 in the effectiveness analysis). Mean disease duration was 11 months before study enrolment; at baseline, mean (standard deviation) Expanded Disability Status Scale was 0.6 (1.0); T2 lesion number 18.3 (15.1). Mean annualised relapse rate during the study was 0.7 (n=57), 28/57 patients (49.1%) had no relapses and for 40/52 (76.9%) no Expanded Disability Status Scale progression was observed; 23/56 (41.1%) were relapse- and progression-free to last follow-up. Neuropsychological test and fatigue scores were within normal ranges (baseline and last follow-up). Eighteen patients had fatigue at some point. New T2 and gadolinium-enhancing (Gd+) lesions were seen in 43/55 (66.2%) and 29/55 (52.7%) patients respectively. Most frequent adverse events were influenza-like illness, headache, injection-site reactions and elevated liver enzymes.
Conclusion:
Interferon beta-1b is an effective treatment with a favourable safety profile for paediatric patients.
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