Immunomodulatory treatment of early onset multiple sclerosis: results of an Italian Co-operative Study.

The ITEM study group was organised in Italy to evaluate the effectiveness and safety of interferon-beta (IFNbeta) and glatiramer acetate (GA) in multiple sclerosis (MS) patients treated before 16 years of age. Eighty-six patients (58 females) were included in our database: as subjects with pre- and treatment duration <3 months were excluded, the data of 81 subjects were analysed: 51 were treated with IFNbeta-1a 6 million once weekly (Avonex), 19 with IFNbeta three times weekly (16 with Rebif, 3 with Betaferon) and 11 with GA (Copaxone). The mean age at onset was 12.4 (SD 2.4) years and the mean pre-treatment duration was 19.7 (SD 25.5) months. After a treatment duration of 36.1 (SD 24.2) months, the mean annualised relapse rate decreased from 2.8 (SD 2.6) to 0.5 (SD 0.7). The EDSS score remained unchanged (basal=1.4, final=1,4). Clinical side effects were recorded in 46 subjects of the IFNB group, transient in 35 (flu-like syndrome in 24, headache in 12, myalgia in 10, injection reaction in 5, fever in 3) and persistent in 11 (headache in 5, fever in 4, flu-like syndrome in 3, myalgia in 3, injection reaction in 1). In the GA-treated group, side effects were recorded in 3 cases: injection reaction in 2 and transient chest pain in 1. Abnormal laboratory findings (mainly reduction of WBC) were observed in 24 subjects (transient in 22). Nine subjects treated with Avonex discontinued the treatment: 7 shifted to Rebif, 2 stopped the therapy. Four subjects treated with INFbeta three times weekly shifted to other medications and 2 increased the dose. Four subjects treated with GA discontinued the treatment: 3 shifted to other medications and 1 stopped GA because of injection reaction. On the whole, 3 cases stopped the treatment definitively. To conclude 81, clinically definite MS subjects were treated during childhood or adolescence with immunomodulatory drugs. The treatment was generally well tolerated. It reduced the relapse rate and the progression of the disease in most cases.