Chronic black holes (BHs) indicate severe tissue injury and are used as a biomarker of therapeutic outcomes in relapsing-remitting multiple sclerosis (RRMS).
Evaluate the effect of peginterferon beta-1a every 2 weeks on the number of chronic BHs that evolve from acute lesions over 2 years.
Patients and methods
ADVANCE was a 2-year, double-blind phase 3 trial of peginterferon beta-1a in 1512 patients with RRMS. The number of BHs at week 96 that evolved from new/enlarging T2-weighted (NET2) lesions at 24 or 48 weeks or gadolinium-enhancing (Gd+) lesions (at baseline, 24 weeks, or 48 weeks) were compared. The adjusted annualized relapse rate (ARR) by BH conversion status was also assessed.
ADVANCE included 231 newly diagnosed and 281 non-newly diagnosed patients in the continuous-treatment group and 229 newly diagnosed and 271 non-newly diagnosed patients in the delayed-treatment group. At week 96, the continuous-treatment ITT patients had fewer BHs that evolved from NET2 lesions at week 24 or week 48 than the delayed-treatment ITT patients in both newly diagnosed (P<0.0001) and non-newly diagnosed (P<0.0001) subgroups.
The results are similar for the BHs that evolved from the Gd+ lesions detected at baseline, week 24 or week 48 in newly diagnosed (P<0.0001) and non-newly diagnosed (P<0.0001) subgroups of ITT patients with MRI measurements.
The lower risk of chronic BHs with peginterferon beta-1a therapy suggests the potential to provide treatment benefits to patients with RRMS by reducing long-term disability.Le texte complet de cet article est disponible en PDF.
Keywords : Peginterferon beta-, Trous noirs, ADVANCE