Temporal evolution of new T1-weighted hypo-intense lesions and central brain atrophy in patients with a first clinical demyelinating event treated with subcutaneous interferon β-1a

H. Vrenken, M. Battaglini, M. L. de Vos, G. J. Nagtegaal, B. C. A. Teixeira, A. Seitzinger, D. Jack, M. P. Sormani, B. M. J. Uitdehaag, A. Versteeg, G. Comi, L. Kappos, N. de Stefano, F. Barkhof

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Objective: Evaluate the effect of subcutaneous interferon β-1a (sc IFN β-1a) versus placebo on the evolution of T1-weighted MRI lesions and central brain atrophy in in patients with a first clinical demyelinating event (FCDE). Methods: Post hoc analysis of baseline-to-24 month MRI data from patients with an FCDE who received sc IFN β-1a 44 μg once- (qw) or three-times-weekly (tiw), or placebo, in REFLEX. Patients were grouped according to treatment regimen or conversion to clinically definite MS (CDMS) status. The intensity of new lesions on unenhanced T1-weighted images was classified as T1 iso- or hypo-intense (black holes) and percentage ventricular volume change (PVVC) was assessed throughout the study. Results: In patients not converting to CDMS, sc IFN β-1a tiw or qw, versus placebo, reduced the overall number of new lesions (P < 0.001 and P = 0.005) and new T1 iso-intense lesions (P < 0.001 and P = 0.002) after 24 months; only sc IFN β-1a tiw was associated with fewer T1 hypo-intense lesions versus placebo (P < 0.001). PVVC findings in patients treated with sc IFN β-1a suggested pseudo-atrophy that was ~ fivefold greater versus placebo in the first year of treatment (placebo 1.11%; qw 4.28%; tiw 6.76%; P < 001); similar findings were apparent for non-converting patients. Conclusions: In patients with an FCDE, treatment with sc IFN β-1a tiw for 24 months reduced the number of new lesions evolving into black holes.

Original languageEnglish
Pages (from-to)2271-2282
Number of pages12
JournalJournal of neurology
Issue number4
Early online date2023
Publication statusPublished - Apr 2023


  • Black-hole lesions
  • Brain atrophy
  • First clinical demyelinating event
  • Interferon β-1a
  • Lesion evolution
  • White matter tracts

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