MS Relapses, Health Care Utilization Greatest Among COVID-19 Vaccinated Patients Treated With Ocrelizumab, Fingolimod

NarmitaTundia, PhD, MS

Relapses and health care resource utilization (HCRU) were greatest within the ocrelizumab and fingolimod patient cohort, among a population of patients with multiple sclerosis (MS) treated with disease-modifying therapies (DMTs) who also had complete COVID-19 vaccination, a recent retrospective study found.¹

Data were presented by NarmitaTundia, PhD, MS, director, Global Evidence and Value Development, EMD Serono, Inc, at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, February 24-26, in West Palm Beach, Florida. Adult patients with MS in the TriNetX Network who had received complete COVID-19 vaccination status, defined as receipt of the second dose or an mRNA vaccine or a single dose of a vector-based vaccine, between Jan 1, 2021, and July 21, 2021, were included in the study.

Investigators compared relapse, severe relapse, and HCRU rates between cohorts of patients, which were defined as treated with anti-CD20s, ocrelizumab, ofatumumab, siponimod, or fingolimod (Cohort 1 [C1]; n = 518), those treated with other DMTs (C2; n = 1312) and those who were untreated (C3; n = 3630). In C1, the majority of patients were taking ocrelizumab (62%), and in C2, the majority were taking glatiramer acetate (30%) or dimethyl fumarate (30%). A relapse was defined as steroid use in any setting, while a severe relapse was defined as steroid use in an inpatient setting, recorded 14 or more days after the index date.

Adjusted incidence rate ratios (IRs) of relapses per 1000 person-days were 3.1 (95% CI, 2.5-3.7) in C1, 1.8 (95% CI, 1.5-2.0) in C2, and 2.3 (95% CI, 2.1-2.5) in C3. IRs of serious relapses per 1000 person-days were 0.15 (95% CI, 0.06-0.34) in C1, 0.07 (95% CI, 0.03-0.14) in C2, and 0.05 (95% CI, 0.03-0.09) in C3.

When comparing C1 with C3, the adjusted incidence rate ratio (IRR) for relapses was 1.3 (95% CI, 1.1-1.6) and for serious relapses, it was 2.7 (95% CI, 1.0-7.5). C2 and C3 were also compared, with an IRR of 0.8 (95% CI, 0.7-0.9) for relapses and 1.3 (95% CI, 0.5-3.3) for serious relapses.

Tundia et al defined HCRU as MS case in any (aHCRU) and inpatient (iHCRU) settings. IR of aHCRU and per 1000 person-dayswere 32.2 (95% CI, 29.1-35.6) in C1, 28.1 (95% CI, 26.3-30.0) in C2, and 21.4 (95% CI, 20.1-22.8) in C3. IRs of adjusted iCHRU per 1000 person-dayswere 7.6 (95% CI, 6.4-8.9) in C1, 6.0 (95% CI, 5.5-6.6) in C2, and 4.5 (95% CI, 4.2-4.8) in C3.

The IRR was 1.5 (95% CI, 1.2-1.7) for aHCRU when comparing C1 with C3, and the IRR was 1.7 (95% CI, 1.4-2.0) for iHCRU when comparing the same 2 groups. Comparing C2 with C3, investigators found the IRR was 1.3 (95% CI, 1.2-1.5) for aHCRU and 1.4 (95% CI, 1.2-1.6) for iHCRU.

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“MS patients treated with antiCD20 therapies, including ocrelizumab and fingolimod, show reduced response to COVID-19 vaccines, whereas response is similar between other DMT and untreated MS patients,” Tundia et al wrote.¹ “Few studies have characterized MS outcomes among vaccinated patients.”

To be included, patients had a visit more than 6 months before complete COVID-19 vaccination, and were excluded if complete vaccination status was undetermined, or in the event they switched treatment over follow-up. Categorization in C1, C2, or C3 was based on treatment status closest to the index date. Poisson models that compared the three groups were adjusted for baseline characteristics, including demographics, HCRU, steroid use, COIVD-19 diagnosis, comorbidities, and expanded disability status scale score, using inverse probability of treatment weights. Investigators defined person-days as the amount accrued from the index date to relapse or the date of the last recorded electronic medical record (EMR) fact for relapse and serious relapse to the last recorded EMR fact for aHCRU and iHCRU.

Additional data were presented at ACTRIMS Forum 2022 that suggest health care providers should take risks of severe COVID-19 infection into consideration before starting immunosuppressive disease-modifying therapy (IS-DMT) in patients with multiple sclerosis. Investigators, led by ZhilaMaghbooli, PhD, MSc, Neuroscience Institute, Multiple Sclerosis Research Center, Tehran University of Medical Sciences, Iran, evaluated the main risk factors related to adverse clinical outcomes in patients with MS who developed COVID-19 and found that those on IS-DMT were found to have longer hospitalized when compared with those on immunomodulatory-DMT.²

For more coverage of ACTRIMS Forum 2022, click here.

REFERENCES
1. Kuranz S, Landsman-Blumberg P, Wong S, Tundia N. Rates of multiple sclerosis relapse, and health care resource utilization following COVID-19 vaccination: A real-world evidence from a US EMR Network. Presented at 2022 ACTRIMS Forum; February 24-26; West Palm Beach, FL and Virtual. Poster P145.
2. Maghbooli Z, Aghababaei Y, Hosseinpour H, et al. Association between disease-modifying therapies and adverse clinical outcomes in multiple sclerosis patients with COVID-19 infection. Presented at 2022 ACTRIMS Forum; February 24-26; West Palm Beach, FL and Virtual. Poster P124.