OLIKOS Study Design: Exploring Maintained Ofatumumab Efficacy in Relapsing MS Patients who Transition from Intravenous Anti-CD20 Therapy (4567)

Objective: OLIKOS, a 12-month, prospective, single-arm, multicenter Phase 3b study, will explore maintained efficacy in patients with relapsing multiple sclerosis (RMS) transitioning from intravenous anti-CD20 monoclonal antibody (mAb) therapy to ofatumumab. Background: B-cell depletion in RMS patients using anti-CD20 mAbs reduces annualized relapse rates and inflammatory lesion activity on MRI, and delays time to confirmed disability worsening. Anti-CD20 mAbs ocrelizumab and rituximab are administered intravenously in clinic; ofatumumab is administered subcutaneously with an autoinjector pen, facilitating patient-administration at home. No outcome data exist relating to transition from ocrelizumab/rituximab treatment to ofatumumab. Design/Methods: Approximately 100 adults with RMS will be enrolled at 10–20 US centers. Eligible patients will have been previously treated with 2–5 consecutive courses of ocrelizumab/rituximab, with last dose 4–9 months before OLIKOS baseline. Other inclusion criteria are EDSS score ≤5.5 at screening and CD19 B-cell count Results: The detailed study design for the OLIKOS trial will be presented. The trial will generate efficacy, retention, and satisfaction data from RMS patients transitioning from intravenous anti-CD20 therapies to ofatumumab. Conclusions: OLIKOS will provide important data on the maintenance of efficacy in RMS patients transitioning from intravenous anti-CD20 therapies to ofatumumab. Disclosure: Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genzyme. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Alvarez has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GCSO. Dr. Foley has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Foley has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Foley has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Foley has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Foley has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genzyme. Dr. Foley has received stock or an ownership interest from InterPRO Bioscience. Dr. Foley has received stock or an ownership interest from Abreos. Dr. Foley has received stock or an ownership interest from Octave. The institution of Dr. Foley has received research support from Biogen. The institution of Dr. Foley has received research support from Novartis. The institution of Dr. Foley has received research support from Adamas. The institution of Dr. Foley has received research support from Octave. The institution of Dr. Foley has received research support from Mallinckrodt. The institution of Dr. Foley has received research support from Genentech. Dr. Henry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MEDDAY. Dr. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Henry has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi/Genzyme. Dr. Brown has received personal compensation for serving as an employee of Novartis Pharmaceuticals Corporation. Elizabeth Camacho has received personal compensation for serving as an employee of Novartis . Dr. Meng has nothing to disclose. Dr. Ziehn has received personal compensation for serving as an employee of Novartis AG. Brandon Brown has nothing to disclose. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bio. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abcam. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Rubin Anders. The institution of Dr. Greenberg has received research support from CLENE Nanomedicine. The institution of Dr. Greenberg has received research support from PCORI. The institution of Dr. Greenberg has received research support from Guthy Jackson Charitable Foundation. The institution of Dr. Greenberg has received research support from Siegel Rare Neuroimmune Association. The institution of Dr. Greenberg has received research support from National MS Society. Dr. Greenberg has received publishing royalties from a publication relating to health care. Dr. Greenberg has a non-compensated relationship as a Scientific Board with Siegel Rare Neuroimmune Association that is relevant to AAN interests or activities.