CHAMPIONS was a 10-year open-label, prospective follow-up of the pivotal phase 3 CHAMPS study (Study 2) and the CHAMPIONS 5-year follow-up.
In the CHAMPIONS prospective 10-year follow-up study, patients randomly assigned in CHAMPS to receive 30 mcg of IM interferon beta-1a once a week were characterized as the immediate treatment (IT) group (n=81), and those randomly assigned to receive placebo were characterized as the delayed treatment (DT) group (n=74).
For the IT group, treatment with AVONEX was initiated early, that is, within a month after onset of clinically isolated syndrome (CIS), and for the DT group treatment was initiated a median of 30 months (interquartile range, 24-35 months) after CHAMPS randomization.
All patients were offered, but not required, to take 30 mcg of IM interferon beta-1a once a week at enrollment. All MS-related disease-modifying therapies (DMTs) and symptomatic therapies (with the exclusion of investigational therapies) were prescribed at the discretion of the study investigator and in accordance with local practices.
aAlternative (other) therapies included SC interferon beta-1b and interferon beta-1a, glatiramer acetate, intervals of high-dose corticosteroid treatment, mitoxantrone hydrochloride, and natalizumab.
CHAMPIONS was funded by Biogen.
Early treatment with AVONEX reduced rate of progression to CDMS at 10 years
At 10 years, the cumulative probability of developing clinically definite multiple sclerosis (CDMS)b was significantly lower in the IT group (58% [95% CI, 48%-68%]) than the DT group (69% [95% CI, 61%-78%]) (unadjusted hazard ratio, 0.64 [95% CI, 0.48-0.87]; P=0.004). The treatment effect was comparable when adjusting for age, CHAMPS qualifying event, number of CHAMPS baseline T2 lesions, and baseline number of Gd+ lesions (adjusted hazard ratio, 0.61 [95% CI, 0.45-0.82]; P=0.001).
bDefined as development of a second exacerbation in an anatomically distinct region of the central nervous system in patients with CIS.
cKaplan-Meier rates for the development of CDMS calculated using timing from the first month. Patients not meeting the criteria for CDMS were censored on the date of their last neurologic examination.
ASSURANCE, a multicenter, observational, single-time-point evaluation of patients conducted 15 years after the MSCRG pivotal trial (Study 1), evaluated the impact of AVONEX treatment on long-term disability in patients who completed 2 years in the MSCRG study.
The primary endpoints of ASSURANCE were change in EDSS score from baseline (start of MSCRG study) and percentage of patients with EDSS scores of at least 4, at least 6, and at least 7. Physician-measured EDSS scores were obtained during the original MSCRG study. Patient-reported EDSS scores were used for the 15-year time point.
In the ASSURANCE 15-year follow-up study, patients were eligible regardless of current treatment or treatment assignment in the MSCRG study. Deceased patients were included if they were deceased at the time of the 8-year follow-up and/or if they were listed in a public database as deceased. A total of 172 patients from the MSCRG study were eligible, and 122 living patients (71%) were enrolled in ASSURANCE. An additional 14 patients (8%) were deceased. Thus, we were able to determine the status of 79% (136/172) of the eligible patients. The analysis focused on the 122 living patients.
Propensity scores were calculated to estimate the probability of current AVONEX treatment given the observed baseline covariates. Propensity score analysis is a rigorous statistical technique used in observational studies to correct for any measured baseline differences between nonrandomized groups.
dPatients not currently taking AVONEX were either not on any therapy or were using different medications, including natalizumab, glatiramer acetate, SC interferon beta-1b, SC interferon beta-1a, and methotrexate.
ASSURANCE was supported and funded by Biogen.
At 15-year follow-up, patients on AVONEX experienced less disability compared with patients not currently taking AVONEX
Nearly half the patients enrolled in ASSURANCE were taking AVONEX at
Abbreviations: CHAMPIONS, Controlled High-Risk AVONEX Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance; CHAMPS, Controlled High-Risk AVONEX Multiple Sclerosis Prevention Study; IM, intramuscular; SC, subcutaneous; ASSURANCE, ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs; MSCRG, Multiple Sclerosis Collaborative Research Group.