RENEWED: long-term electrophysiological and clinical outcomes in participants previously enroled in the opicinumab phase 2 study RENEW

Objective: To assess long-term electrophysiological and clinical outcomes in participants previously enrolled in RENEW. Background: The randomized, double-blind study RENEW (NCT01721161) assessed the efficacy and safety of opicinumab (anti-LINGO-1) at 100 mg/kg every 4 weeks in patients with first-episode acute optic neuritis (AON). The pre-specified per-protocol (PP) population showed better recovery on visual evoked potential (VEP) latency with opicinumab versus placebo. Design/Methods: 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. Results: 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. Conclusions: 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) Disclosure: Dr. Aktas has received personal compensation from Almirall, Bayer HealthCare, Biogen, Genzyme, MedImmune, Merck Serono, Novartis, Roche, Teva, Viela Bio. Dr. Aktas has received research support from Bayer HealthCare, Biogen, Genzyme, Novartis, Teva and Viela BioDr. Ziemssen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with consulting fees from Alimera, Allergan, Bayer HealthCare, Boehringer-Ingelheim, Novartis, NovoNordisk, MSD and Roche. Dr. Ziemssen has received research support from Novartis. Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) grant/research support (Biogen, Novartis, Sanofi, and Teva)Dr. Comi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with honoraria for consultancy and/or speaking activities from Almirall, Biogen, Bayer, Chugai, Genzyme, Merck Serono, Novartis, Roche, Receptos, Sanofi, Serono Symposia International Foundation, and Teva.. Dr. Comi has received personal compensation in an editorial capacity for Clinical Investigation; European Journal of Neurology and Multiple Sclerosis; Neurological Sciences. Dr. Butzkueven has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Institution (Monash University) received compensation for consulting, talks, advisory/steering board activities from Alfred Health, Biogen, Genzyme, Merck, Novartis. Dr. Butzkueven has received research support from Research support from Biogen, Merck, MS Research Australia, National Health and Medical Research (Australia), Novartis, Oxford Health Policy Forum, Pennycook Foundation, Roche. Dr. Izquierdo Ayuso has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen-Idec, Novartis, Sanofi, Merck-Serono, Almirall, Roche, Actelion, Celgene, and Teva.Dr. Klistorner has nothing to disclose. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Cheng holds stock and/or stock options in Biogen which sponsored research in which Dr. Cheng was involved as an investigator. Dr. Cheng holds stock and/or stock options in Biogen. Dr. Naylor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Maria L. Naylor is an employee and shareholder of Biogen.. Dr. Naylor holds stock and/or stock options in Maria L. Naylor is an employee and shareholder of Biogen. which sponsored research in which Dr. Naylor was involved as an investigator. Dr. Naylor has received research support from Maria L. Naylor is an employee and shareholder of Biogen.. Dr. Gheuens has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen.Dr. Zhu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Zhu holds stock and/or stock options in Holds stock/stock options in Biogen.