RENEWED (NCT02657915) was a 1-day follow-up study at 2 years (+up to 12 months) after the last study visit (Week 32) or after the projected last visit, if the participant did not complete all visits in RENEW. The primary endpoint was the change in full field (FF)-VEP latency of the affected eye on Day 1 versus baseline of the fellow eye in RENEW. Change in latency from baseline with multifocal (mf)-VEP was assessed in a substudy. Clinically definite MS (CDMS)/time to diagnosis of CDMS was a secondary endpoint. Primary analysis was performed in the PP population of RENEW.

52/82 (63.4%) of RENEW participants enrolled and completed RENEWED (opicinumab n=28, placebo n=24). At follow-up, the adjusted mean (95% CI) difference in FF-VEP latency recovery between opicinumab and placebo groups was –6.0 (–14.6, 2.6) msec (P=0.17) in the PP population, and –4.48 (–12.61, 3.66) msec (P=0.27) in the intention-to-treat population. Consistently, the mfVEP sub-study (opicinumab n=9; placebo n=9) showed a smaller latency delay in the affected eye with opicinumab versus placebo treatment. At Day 1, 55% of the opicinumab group and 67% of the placebo group presented with CDMS; median time to CDMS diagnosis post-enrollment in RENEW was 909.5 days and 386.0 days, respectively.

While acknowledging the limitations of the study, the effects on VEP latency recovery after AON appeared to be maintained 2 years post opicinumab treatment.

Study Supported by: Biogen (Cambridge, MA, USA)