Early IFN Treatment Associated with Better NEDA Rates than Delayed Treatment in CIS

Early IFN Treatment Associated with Better NEDA Rates than Delayed Treatment in CIS
Early IFN Treatment Associated with Better NEDA Rates than Delayed Treatment in CIS

VANCOUVER, BC—Early administration of subcutaneous interferon (sc IFN) β-1a is associated with better rates of no-evidence-of-disease-activity (NEDA) status than delayed treatment among patients with clinically isolated syndrome (CIS), according to a research-poster presentation at the 68th AAN Annual Meeting. 

“Early treatment with scIFN β-1a was associated with more patients achieving NEDA status, compared with delayed treatment, for up to 5 years,” wrote Patricia K. Coyle, MD, of Stony Brook University, Stony Brook, NY, and coauthors. 

Previous research has shown that early scIFN β-1a treatment (44µg) significantly improves clinical and magnetic resonance imaging (MRI) patient outcomes for up to 5 years, the authors noted. NEDA is a composite clinical and MRI endpoint used to measure disease-modifying treatment efficacy for patients with multiple sclerosis (MS). 

In order to compare NEDA status following early and delayed scIFN β-1a administration, the researchers conducted post-hoc analysis of NEDA status among a total of 517 intent-to-treat patients who had participated in the REFLEX and REFLEXION (REFLEX extensION) studies (NCT00813709).

“NEDA was defined as no relapses, no confirmed disease worsening (no increase in EDSS [Expanded Disability Status Scale] score), and no MRI activity (no new or enlarging T2 or gadolinium-enhancing lesions),” they wrote. 

Patients in the REFLEX trial were randomly assigned after CIS diagnosis to an early-treatment group (scIFN β-1a 44µg three times weekly or once weekly) or placebo, for 24 months. Patients diagnosed with clinically-definite MS (CDMS) were switched to open-label scIFN β-1a 44µg three times weekly. Placebo group patients and patients diagnosed with CDMS in the REFLEXION study, were switched to scIFN β-1a 44µg three times weekly; these patients represented the delayed-treatment study group.

“A dose-dependent, higher proportion of early treatment vs. delayed treatment patients achieved NEDA at each time point,” the authors reported. “At up to 1 year, patients receiving early treatment [three-times-weekly or once-weekly] were more likely to achieve NEDA than those receiving delayed treatment.” 

The odds ratios (OR) for early administration of scIFN β-1a three times weekly vs. delayed treatment was 3.32 (95% CI: 1.93–5.69) and the OR for once-weekly early treatment vs. delayed treatment was 1.95 (95% CI: 1.12–3.40), the authors wrote.

“scIFN β-1a 44µg three times weekly was more likely to lead to NEDA at Years 2, 3 and 5 than delayed treatment,” they reported. “Overall, more patients treated early with scIFN β-1a 44µg three times weekly than those with delayed treatment had radiological activity-free status at 5 years (P=0.001).”

The study was funded by Merck KGaA. 

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