Subcutaneous Interferon Beta-1a in Pediatric Multiple Sclerosis

Abstract

To expand current knowledge, we examined the safety and tolerability of subcutaneous interferon β-1a in patients with pediatric-onset multiple sclerosis. Records from 307 patients who had received at least 1 injection of subcutaneous interferon β-1a for demyelinating events when aged younger than 18 years were reviewed. Overall, 168 (54.7%) patients had at least 1 prespecified medical event related to or under close monitoring with subcutaneous interferon β-1a or specific to pediatric patients, 184 (59.9%) had nonserious medical events related to treatment or of unknown causality, and 12 (3.9%) had serious medical events irrespective of causality. The most common laboratory abnormalities were increased alanine (74/195; 37.9%) and aspartate aminotransferase levels (59/194; 30.4%). Annualized relapse rates were 1.79 before treatment and 0.47 during treatment. In conclusion, adult doses of subcutaneous interferon β-1a (44 and 22 μg, 3 times weekly) were well tolerated in pediatric patients and were associated with reduced relapse rates.

Pediatric multiple sclerosis

“…Based on the results from a recently published study by Tenembaum et al, 22 the label of IFNb-1a 22 or 44 mg has been modified in the European Union as follows: "The results of this study suggest that the safety profile in children (2-11 years old) and in adolescents (12-17 years old) receiving Rebif 22 or 44 mg subcutaneous 3 times per week is similar to that seen in adults. The safety and efficacy of Rebif in children below 2 years of age have not yet been established.…”

“…1,3 The European document suggested early use of DMTs to prevent relapses, accumulation of disability, and accumulation of brain damage, recommending careful clinical and MRI follow-up. 3 Similarly, the International Pediatric Multiple Sclerosis Study Group consensus statement Table 1 Demographic and clinical findings of studies a evaluating the results of interferon-b (IFN-b) and glatiramer acetate in pediatric patients with multiple sclerosis Waubant et al 16 Mikaeloff et al 17 Ghezzi et al 21 Pohl et al 19 Tenembaum and Segura 20 Ghezzi et al 21 Tenembaum et al 22 Banwell et al 23 Mikaeloff et al 24 Kornek et al 25 Ghezzi et al 21 Drug The general approach is shown in the figure.…”

“…Patients treated with IFN-b can develop neutralizing antibodies resulting in a reduced biological activity of this medication and an increased risk of relapses 30,31 : according to these recommendations, testing for the presence of neutralizing antibodies (NAbs), if available, should be performed in patients Table 2 Adverse events in children compared to adolescents or to the whole cohort of patients with multiple sclerosis Ghezzi et al 21 Tenembaum and Segura 20 Ghezzi et al 21 Tenembaum et al 22 Banwell et al Switching to a second-line therapy can be considered for patients who do not adequately respond to current first-line therapies.…”

“…22 Rare adverse events (less than 2%) noted in this study included allergic reactions in 5 patients (1.6%), epilepsy and convulsive disorders in 5 (1.6%), thyroid dysfunction in 3 (1.0%), and autoimmune disorders, bone/cartilage disorders, and serious infections in 2 patients, respectively (0.7%). One child required omentectomy, classified under malignancy in Medical Dictionary for Regulatory Activities Query, and considered not related to IFN-b treatment by the treating physician.…”

“…[15][16][17][18][19][20][21][22][23][24][25] Data from observational studies are available in about 600 patients treated with IFN-b: 7 studies included .20 patients; 6 have a follow-up of 2 years or more.…”