Cross-sectional study assessing long-term safety of interferon-ß-1b for relapsing-remitting MS  

Oleh:

Reder, A.T. ; Ebers, G.C. ; Traboulsee, A.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Neurology (Official Journal of The American Academy of Neurology) vol. 74 no. 23 (Jun. 2010), page 1877-1885.
Topik: interferon; multiple sclerosis

Ketersediaan

Perpustakaan FK Nomor Panggil: N11.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Objective: The 16-Year Long-Term Follow-Up (LTF) to the pivotal interferon-ß-1b (IFNß-1b) trial explored clinical, MRI, cognitive, and patient-reported outcomes. Here, we report the safety assessments. Methods: In the pivotal study, 372 patients were randomized to placebo (n = 123), IFNß-1b 50 µg (n = 125), or IFNß-1b 250 µg (n = 124) subcutaneously every other day for up to 5 years. Sixteen years later, patients were asked to participate in this cross-sectional follow-up study. No particular therapy was stipulated during follow-up. Adverse events experienced since the pivotal trial were recorded. Neutralizing antibodies (NAbs) to IFNß-1b were measured using the myxovirus protein A induction assay. Statistical analyses were descriptive. Results: In total, 88.2% of patients (328/372) were identified. Some centers achieved 100% ascertainment, obviating selection bias. Treatment-related adverse events (e.g., leukopenia and liver and thyroid dysfunction) reported by LTF participants were in keeping with those previously established. Based on a follow-up period that includes 2,000 patient-years of IFNß-1b treatment, no new adverse events were observed that were associated with long-term IFNß-1b exposure. By LTF, NAbs to IFNß-1b disappeared in the majority (76%) of NAb-positive patients. NAb status during the pivotal study appeared to have no impact on long-term clinical and MRI outcomes. There were more deaths among patients assigned to placebo in the pivotal study (20/109 [18.3%]) compared with patients who received IFNß-1b 50 µg (9/108 [8.3%]) or IFNß-1b 250 µg (6/111 [5.4%]). Conclusion: The results from the 16-Year Long-Term Follow-Up study support the long-term safety of interferon-ß-1b therapy in multiple sclerosis.

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