Abstract Details

Title Evaluating the Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Infusion Related Reactions in Relapsing Forms of Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-015

Objective To assess the frequency and severity of infusion related reactions (IRRs) in patients with relapsing forms of multiple sclerosis switching from rituximab (RTX) to ocrelizumab (OCR).

Background

OCR is more humanized and has increased antibody-dependent cell-mediated cytotoxicity than RTX. Safety in transitioning from RTX to OCR is unknown in regards to IRRs.

Design/Methods Patients with >2 courses of RTX consented into either a prospective SWITCH group that received OCR on Days 1, 15, and week 24 or a COMPARATOR group (n=100 each) who stayed on RTX for two infusions at the Rocky Mountain MS Center at University of Colorado. Primary outcome was IRR frequency. Factors impacting IRRs were described using generalized estimating equation models.

Results Both groups had similar baseline characteristics with regard to age, gender, disease duration, number of prior DMTs and doses/time on RTX. Unadjusted differences showed 14% of COMPARATOR and Day 1 SWITCH patients had any IRRs (p=1.000). Compared to COMPARATOR, day 15 SWITCH patients only had 4% IRRs (p=0.005) and 12% at week 24(p=0.647). No IRRs of Grade >3 were present in either group. We explored factors that affected IRRs in the COMPARATOR group, the risk of IRRs decreased by 45% with each doubling in the number of infusions after adjusting for age, gender, MS disease duration, and BMI(p=0.0389). For Day 1 of the SWITCH patients, IRRs occurred in 5.4% (3/56) if CD19 and/or CD20 were ≤1% but 26.2% (11/42) if >1% with the risk of IRRs increasing by a factor of 3.87 after adjusting for the number of prior RTX infusions, time since last RTX infusion, age, gender, MS disease duration, and BMI (p=0.02).

Conclusions

IRRs are similar with RTX and OCR suggesting that it is safe to switch between them. IRRs appear to be related at least in part to B cell levels.

Authors/Disclosures
Enrique Alvarez, MD, PhD (University of Colorado) PRESENTER	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 TG Therapeutics. 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 Biogen. 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 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/BMS. The institution of an immediate family member of 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 UCB. The institution of 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 Horizon.
Kavita Nair, PhD, FAAN (University of Colorado)	Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PhRMA Foundation. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MJH Lifesciences. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Anylam . Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Applied Patient Experience. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Esai. Dr. Nair has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MHJ Life Sciences. Dr. Nair has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Nair has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for ICER. The institution of Dr. Nair has received research support from Genentech. The institution of Dr. Nair has received research support from Novartis. The institution of Dr. Nair has received research support from Genentech. The institution of Dr. Nair has received research support from Phrma Foundation. The institution of Dr. Nair has received research support from Bristol Meyers Squibb. The institution of Dr. Nair has received research support from Novartis. The institution of Dr. Nair has received research support from NINDS. The institution of Dr. Nair has received research support from Sanofi Genzyme. The institution of Dr. Nair has received research support from Kyverna Therapeutcis. Dr. Nair has a non-compensated relationship as a Board Member with Center for Improving Value in Healthcare that is relevant to AAN interests or activities.
	No disclosure on file
Sean Selva	Sean Selva has nothing to disclose.
	No disclosure on file
Nassim Zanganeh, MS (University of Colorado Denver Anschutz Medical Campus)	No disclosure on file
Stefan Sillau	Stefan Sillau has nothing to disclose.
Timothy L. Vollmer, MD, FAAN	The institution of Dr. Vollmer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen IDEC. The institution of Dr. Vollmer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siranax. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers Squib. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bios. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Vollmer has received research support from Rocky Mountain MS Center. The institution of Dr. Vollmer has received research support from Biogen. The institution of Dr. Vollmer has received research support from Actelion. The institution of Dr. Vollmer has received research support from Genentech/Roche. The institution of Dr. Vollmer has received research support from Anokion. The institution of Dr. Vollmer has received research support from TG Therapeutics.

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