Abstract Details

Title Serious Infections in Two Large US and Swedish Rituximab-treated Multiple Sclerosis Cohorts

Topic Multiple Sclerosis

Presentation(s) S26 - MS and CNS Inflammatory Disease: Clinical Considerations II (2:06 PM-2:17 PM)

Poster/Presentation
Number 007

Background Long-term safety data, including serious infections, in large real-world cohorts of multiple sclerosis (MS) patients treated with anti-CD20 drugs are limited. Ocrelizumab trials raised concern for increased risk of sepsis/SIRS and pneumonia. Other highly effective MS treatments are complicated by progressive multifocal leukoencephalopathy (PML) and serious herpes-family virus infections.

Objective To describe serious infections in MS patients treated with rituximab (RTX-MS).

Design/Methods Hospitalizations for infections among RTX-MS patients in Kaiser Permanente Southern California (KPSC) in 2008-mid-2018 were identified from complete electronic health records after abstraction of those with primary or secondary discharge diagnoses for any infection. The COMBAT-MS study, a chart-validated subset of the Swedish MS Register, identified RTX-MS patients through 12/31/2017 and primary discharge diagnoses from a national registry. Infections related to advanced MS (e.g. urosepsis with Foley, aspiration pneumonia) were not considered RTX-related.

Results We identified 1450 RTX-treated MS/NMO patients with 3363.2 person-years of follow-up in KPSC. The mean age at first RTX dose was 44.6 years, 94.2% had MS and 17 had been hospitalized for infections prior to RTX-start. 85 patients (5.9%) were hospitalized a total of 180 times for serious infections after RTX-initiation, of which 91.8% were most likely related to advanced MS. In 13 patients (0.9%) the infections seem RTX-related. Crude RTX-related serious infection rates were 4.16 per 1000 person-years. RTX-related serious infections included enterovirus meningitis (n=1); cellulitis (n=1); abscess with sepsis without organ failure (n=2); pneumonia and sepsis without organ failure (n=8) and infectious uveitis (n=1). All 13 patients recovered fully and 12 remain on RTX. No cases of PML were found in KPSC or COMBAT-MS.

Conclusions RTX-related serious infections are rare and thus far all have recovered fully. We found no cases of PML or serious herpes-family virus infections. Whether RTX increases the risk of advanced MS-related infections is unclear. Full Swedish data will be presented.

Authors/Disclosures
Annette M. Langer-Gould, MD, PhD (Kaiser Permanente Southern California) PRESENTER	An immediate family member of Dr. Langer-Gould has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of American Thoracic Society. The institution of Dr. Langer-Gould has received research support from PCORI. The institution of an immediate family member of Dr. Langer-Gould has received research support from PCORI, ARQ, NIH. Dr. Langer-Gould has a non-compensated relationship as a Voting Member with ICER CTAF Panel that is relevant to AAN interests or activities.
Jessica B. Smith, MPH (Kaiser Permanente)	Ms. Smith has nothing to disclose.
Fredrik L. Piehl, MD, PhD (Neuroimmunology Unit, Dept Clinical Neuroscience, Karolinska Institutet)	Dr. Piehl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Parexel/Chugai. The institution of Dr. Piehl has received research support from UCB. The institution of Dr. Piehl has received research support from Merck KGaA. Dr. Piehl has received personal compensation in the range of $10,000-$49,999 for serving as a member scientific advisory board with Swedish Medical products Agency.
Bonnie Li	Bonnie Li has received personal compensation for serving as an employee of Kaiser Permanente.
	No disclosure on file

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