Abstract Details

Title Evaluating the Efficacy and Safety of Transitioning Patients from Natalizumab to Ocrelizumab (OCTAVE)

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-056

Objective To present interim data from OCTAVE, a prospective, observational study to evaluate the efficacy and safety of OCR in RMS patients previously treated with NTZ.

Background

Natalizumab (NTZ) is an effective therapy for patients with relapsing MS (RMS). However, it is associated with a risk of progressive multifocal leukoencephalopathy (PML) in patients infected with John Cunningham virus (JCV). Ocrelizumab (OCR) has demonstrated efficacy, yet its safety in patients previously treated with NTZ is unclear.

Design/Methods Clinically and radiologically stable RMS patients, aged 18-65 treated with NTZ for ≥ 12 months, were started on OCR 4-6 weeks after last dose of NTZ and followed for 12 months. Relapse assessment, Expanded Disability Status Scale (EDSS), and MRI were performed prior to starting OCR and at months 3, 6, 9 (no MRI), and 12

Results

Twenty-one patients, 71.4% female with mean age of 43.7 (±10.6), baseline EDSS of 3.4 (±1.5), and 12.4 (±1.2) NTZ infusions in the 12 months prior have been enrolled between August 2017 and September 2018. Seventeen subjects switched to OCR due to potential PML risk. None of the 16 patients assessed at 6 months discontinued OCR or had a relapse. EDSS and imaging were stable, except for one patient with 3 new T2 lesions. Physical and psychological MSIS-29 improved slightly from 42.1 to 40.7 and 20.1 to 18.6 respectively. Infusion reactions were seen in 38% of patients with the first dose and 12.5 % with the second dose. Four serious adverse events (SAEs) have been reported with two possibly related to OCR, breast cancer and acute cystitis. No cases of PML reported.

Conclusions

The absence of relapses, EDSS progression, and MRI changes to date are encouraging; however, the two possibly related SAEs are concerning given the small number of patients.

Authors/Disclosures
Kyle Smoot, MD, FAAN PRESENTER	Dr. Smoot has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Smoot has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Smoot has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BMS. Dr. Smoot has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for EMDSerono. Dr. Smoot has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Smoot has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for TG Therapeutics. The institution of Dr. Smoot has received research support from Genzyme. The institution of Dr. Smoot has received research support from EMDSerono. The institution of Dr. Smoot has received research support from Genentech.
Chiayi Chen, PhD, RN	Dr. Chen has nothing to disclose.
	No disclosure on file
Lindsay Lucas (Providence Health and Services)	No disclosure on file
Kiren Kresa-Reahl, MD (Atara Biotherapeutics)	Dr. Kresa-Reahl has received personal compensation for serving as an employee of Atara Biotherapeutics Inc.. Dr. Kresa-Reahl has received stock or an ownership interest from Atara Biotherapeutics Inc.
Pavle Repovic, MD, PhD (Multiple Sclerosis Center)	Dr. Repovic has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Repovic has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Repovic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Repovic has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Repovic has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Repovic has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BristolMyersSquibb. Dr. Repovic has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Repovic has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for TG therapeutics. The institution of Dr. Repovic has received research support from Genentech. The institution of Dr. Repovic has received research support from Biogen.
Jessica R. Craddock, MD	No disclosure on file
Stanley L. Cohan, MD, PhD, FAAN	Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb (Celgene). Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Icometrix. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi genzyme. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Icometrix.

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