Patients with relapsing multiple sclerosis (RMS) achieved No Evidence of Disease Activity (NEDA) more frequently if they had received long-term continuous ozanimod therapy than if they had received interferon or transitioned from interferon to ozanimod, a post-hoc analysis of the phase 3 RADIANCE trial (NCT02047734) and the open-label extension DAYBREAK study (NCT02576717) showed. Physician’s Weekly interviewed Prof. Ludwig Kappos (University of Basel, Switzerland), first author of the current post-hoc analysis presented at the American Academy of Neurology 2022 Annual Meeting (“The Great Neuro Reunion”), 2-7 April, held in Seattle, WA, USA, to discuss the findings of this study and its implications for the RMS population .
The composite efficacy outcome ‘no evidence of disease activity’ (NEDA) is an established treatment outcome for patients with MS. Prof. Kappos and colleagues assessed the efficacy of ozanimod by assessing the NEDA status of patients with RMS who had received ozanimod or interferon in the RADIANCE (n=1,320) and DAYBREAK trials (n=2,631). The current post-hoc analysis included patients who had received oral ozanimod, 0.92 mg, once daily, or intramuscular interferon β-1a, 30 μg, once per week. To assess the NEDA-3 and NEDA-4 status of these patients, MRIs were performed at baseline, and at 1-year time intervals.
Patients who had received 24 months of ozanimod therapy displayed significantly higher NEDA-3 rates than patients who were treated with interferon in the RADIANCE trial (24.6% vs 17.0%; P<0.05). In addition, patients who were treated with continuous ozanimod displayed higher NEDA-3 higher than those who transitioned from interferon to ozanimod in the DAYBREAK trial, the 24-month data of this trial showed (13.4% vs 8.6%; P<0.05). Similarly, NEDA-4 rates were significantly higher in patients who received 24 months of ozanimod therapy in the RADIANCE trial compared to those who were treated with interferon (14.0% vs 7.8%; P<0.05). Corresponding figures of the DAYBREAK trial demonstrated a numerical benefit of long-term ozanimod receivers compared to those who transitioned from interferon (10.4% vs 6.2%).
After re-baselining to month 12 of the RADIANCE trial to control for immediate high lesion activity and brain volume loss after treatment initiation, the NEDA-3 rates at 24 months in the RADIANCE trial were 52.6% for patients treated with ozanimod and 33.4% for patients treated with interferon (P<0.05). Moreover, the 24-month data of the DAYBREAK trial showed a higher NEDA-3 rate for patients who received long-term ozanimod therapy compared to those who transitioned from interferon (26.3% vs 17.4%; P<0.05).
Prof. Kappos told our correspondent, “We presented here the follow-up of controlled studies with ozanimod in relapsing multiple sclerosis. All of these studies had a controlled phase where once weekly, intramuscularly ozanimod was compared with interferon ß-1a. We had a high retention rate of included patients who were randomized in the controlled part of the study, and now we have a long follow-up of several years. Our data point to the fact that the positive effects we observed in the controlled part of the study were sustained really well over time. We presented an analysis of the data collected concerning the evidence of disease activity in these patients, namely any signs of relapse or new lesions observed on MRI imaging. Importantly, we also looked at disability progression, which we saw in most patients had stabilized 3 months later. With this long follow-up, we see that the effects in the first year were repeated over time, even with these very strict criteria, and that a significant number of patients remained disease-activity free. Of those participants who did show evidence of disease activity, they were mainly asymptomatic detected through routine MRIs, with minor or no disability progression.”
- Kappos L, et al. Evaluating No Evidence of Disease Activity in Patients With Relapsing Multiple Sclerosis: Post Hoc Analysis of the Phase 3 RADIANCE and Open-Label Extension Studies of Ozanimod. P7.012, AAN 2022 Annual Meeting, 2-7 April.