NEDA (absence of protocol-defined relapses [PDRs], 24-week CDP [24W-CDP], T1-weighted contrast-enhancing [T1-Gd] and new/enlarging T2-weighted [n/e-T2] lesions) is a composite endpoint for assessing treatment efficacy in MS, and may predict future CDP.

In the controlled-treatment periods (CTPs), patients were randomized to ocrelizumab or comparator (OPERA: interferon [IFN]-β-1a; ORATORIO: placebo). At OLE initiation, patients continued ocrelizumab, or switched from IFN-β-1a/placebo to ocrelizumab. Post-hoc analyses assessed 24W-CDP during OLEs, in ocrelizumab-ocrelizumab continuers and IFN-β-1a/placebo-ocrelizumab switchers, between patients with vs without NEDA during CTPs. Hazard ratios (HRs) were estimated by stratified Cox regression.

In IFN-β-1a/placebo-ocrelizumab switchers, NEDA and individual NEDA components during CTPs did not predict future CDP (NEDA: OPERA, HR=0.85 [0.57–1.27], p=0.42; ORATORIO, HR=1.02 [0.53–1.95], p=0.96). In patients with RMS receiving continuous ocrelizumab, 24W-CDP (HR=0.51 [0.30–0.84], p<0.01) and PDRs (HR=0.62 [0.43–0.89], p<0.01) during CTP predicted 24W-CDP during OLE, but there was no significant association between NEDA (HR=0.75 [0.55–1.03], p=0.07) or MRI measures (T1-Gd: HR=1.06 [0.43–2.59], p=0.90; n/e-T2: HR=1.09 [0.78–1.52], p=0.60) during CTP and 24W-CDP during OLE. In patients with PPMS receiving continuous ocrelizumab, NEDA predicted future 24W-CDP (HR=0.63 [0.43–0.92], p=0.02); individually, the only NEDA component significantly correlating between CTP and CDP during OLE was 24W-CDP (HR=0.59 [0.38–0.89], p=0.01).

In ocrelizumab-ocrelizumab continuers, NEDA predicted long-term CDP in PPMS only; previous 24W-CDP predicted future CDP in RMS and PPMS, and relapses were predictive in RMS only. MRI components did not predict CDP. In IFN-β-1a/placebo-ocrelizumab switchers, NEDA and its components did not predict CDP.