Ocrelizumab after natalizumab in JC-virus positive relapsing remitting multiple sclerosis patients

Lierop, Zoë Y. G. J. van; Toorop, Alyssa A; Coerver, E. M. E.; Willemse, Eaj; Strijbis, E. M.; Kalkers, NF; Moraal, Bastiaan; Barkhof, Frederik; Teunissen, C.E.; Killestein, Joep; Kempen, Zle van

doi:10.1177/20552173211013831

Cited by 11 publications

(10 citation statements)

References 11 publications

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“…In this cohort of patients, ocrelizumab following natalizumab in EID was an effective agent to prevent clinical and radiological activity, as well as disability progression. Remarkably, our series of ocrelizumab switchers coming from natalizumab in EID showed a better control of the disease than those previously reported in the literature that switched from natalizumab in SID to ocrelizumab ( 14 , 16 ).…”

Section: Discussionsupporting

confidence: 43%

Switch to ocrelizumab in MS patients treated with natalizumab in extended interval dosing at high risk of PML: A 96-week follow-up pilot study

et al. 2023

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We aimed to assess the long-term safety and effectiveness of ocrelizumab in a cohort of patients with multiple sclerosis (MS) at high risk of progressive multifocal leukoencephalopathy (PML), previously treated with natalizumab in extending interval dosing (EID), who switched to ocrelizumab and to compare them with patients who continued EID-natalizumab. Thirty MS patients previously treated with natalizumab in EID (every 8 weeks) were included in this observational retrospective cohort study. Among them, 17 patients were switched to ocrelizumab and 13 continued with EID-natalizumab. Except for the John Cunningham virus (JCV) index, no significant differences were detected between both groups. Main outcome measures included: annualized relapse rate (ARR), radiological activity, disability progression, and the NEDA-3 index. Patients were followed for 96 weeks. The median washout period in ocrelizumab-switchers was 6 weeks. Among them, AAR and radiological activity during follow-up were 0.03, without significant differences in comparison with the previous period on natalizumab-EID. The comparison between ocrelizumab-switchers and patients continuing on EID-natalizumab showed no significant differences in AAR, radiological activity, or disability progression. However, the proportion of patients maintaining a NEDA-3 status in week 96 was slightly superior among ocrelizumab-switchers (94 vs 69%). No serious adverse events were observed in any group. In conclusion, switching from EID-natalizumab to ocrelizumab can be considered as a therapeutic option, particularly in patients with MS at high risk of PML, to mitigate the risks of both PML and disease reactivation.

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Section: Discussionsupporting

confidence: 43%

Switch to ocrelizumab in MS patients treated with natalizumab in extended interval dosing at high risk of PML: A 96-week follow-up pilot study

et al. 2023

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“…After mean standardization, these patients demonstrated a high number of previous DMTs. Other reports on the efficacy of OCR in switchers from other DMTs have shown that exit strategies from natalizumab/alemtuzumab/rituximab reveal good disease stabilization within the first 6 months or during the first year of therapy, while other data have been reported on switching from first-line therapies [26][27][28][29][30][31]. Our results are in accordance with a recent Italian work on 153 MS patients treated with OCR that suggested that better outcomes were observed in treatment-naïve patients at the 2-year follow-up [32].…”

Section: Discussionmentioning

confidence: 99%

Is It Time for Ocrelizumab Extended Interval Dosing in Relapsing Remitting MS? Evidence from An Italian Multicenter Experience During the COVID-19 Pandemic

Zanghì¹,

Avolio

Signoriello

et al. 2022

Neurotherapeutics

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In the COVID-19 pandemic era, safety concerns have been raised regarding the risk of severe infection following administration of ocrelizumab (OCR), a B-cell-depleting therapy. We enrolled all relapsing remitting multiple sclerosis (RRMS) patients who received maintenance doses of OCR from January 2020 to June 2021. Data were extracted in December 2021. Standard interval dosing (SID) was defined as a regular maintenance interval of OCR infusion every 6 months, whereas extended interval dosing (EID) was defined as an OCR infusion delay of at least 4 weeks. Three infusions were considered in defining SID vs. EID (infusions A, B, and C). Infusion A was the last infusion before January 2020. The primary study outcome was a comparison of disease activity during the A-C interval, which was defined as either clinical (new relapses) or radiological (new lesions on T1-gadolinium or T2-weighted magnetic resonance imaging (MRI) sequences). Second, we aimed to assess confirmed disability progression (CDP). A total cohort of 278 patients (174 on SID and 104 on EID) was enrolled. Patients who received OCR on EID had a longer disease duration and a higher rate of vaccination against severe acute respiratory syndrome-coronavirus 2 (p < 0.05). EID was associated with an increased risk of MRI activity during the A-C interval (OR 5.373, 95% CI 1.203–24.001, p = 0.028). Being on SID or EID did not influence CDP (V-Cramer 0.47, p = 0.342). EID seemed to be associated with a higher risk of MRI activity in our cohort. EID needs to be carefully considered for OCR-treated patients.

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“…Mean IgG levels were generally stable in the VELOCE trial, with some fluctuation over time, and decreased slightly at 24 weeks from baseline (although it should be noted that this vaccine response study had a much shorter follow-up duration of only 24 weeks) [ 19 ]. Similar, albeit less consistent, patterns were also observed in the RWE studies: whereas most studies observed overall decreases in IgG levels over time with ocrelizumab treatment [ 25 , 26 , 28 ], some studies observed stable IgG levels or even slight increases in IgG levels from baseline [ 23 , 24 ]. IgM levels appeared to decrease with ocrelizumab treatment.…”

Section: Discussionmentioning

confidence: 62%

“…Lopez Ruiz et al [ 28 ] reported that no participants exhibited IgG levels < LLN at 78 weeks. It should also be noted that Prezioso et al [ 23 ] (in a single-arm interventional study) and van Lierop et al [ 24 ] (in a cohort study of individuals switching from natalizumab to ocrelizumab either directly or indirectly because of progressive multifocal leukoencephalopathy risk) reported slight increases from baseline in mean and median IgG levels over time with ocrelizumab treatment. Prezioso et al [ 23 ] reported that IgG levels had a stationary trend over time ( P < 0.05) during the 12 months ocrelizumab treatment, whereas van Lierop et al [ 24 ] did not comment on the results.…”

Section: Resultsmentioning

confidence: 99%

Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis

Saidha

Bell²,

Harold³

et al. 2023

Neurol Sci

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Objective To exp lore changes in immunoglobulin (Ig) levels for people with relapsing-multiple sclerosis (RMS) treated with ocrelizumab or ofatumumab and the relationship between Ig levels and infections. Methods A systematic literature review (SLR) was conducted to identify clinical trials and real-world evidence (RWE) studies on Ig levels over time and studies on associations with infections for ocrelizumab and ofatumumab for people with RMS through 10 September 2021. Searches were conducted in Embase, MEDLINE, Cochrane Library, trial registries, and recent conference abstracts. Results Of 1,580 articles identified, 30 reporting on 11 trials and 5 RWE studies were included. Ocrelizumab trials (n = 4) had 24–336 weeks of follow-up and reported decreasing Ig G (IgG) levels, while RWE (n = 5) had 52–78 weeks of follow-up and reported IgG to be stable or decrease only slightly. IgG levels were stable in ofatumumab trials (n = 5; 104–168 weeks of follow-up), but no RWE or longer-term studies were identified. No apparent association between decreased Ig levels and infections was observed during ofatumumab treatment (ASCLEPIOS I/II), while for ocrelizumab, the only data on apparent associations between decreased IgG levels and serious infection rates were for a pooled population of people with RMS or primary progressive MS. Conclusion Decreasing IgG levels have been correlated with increased infection risk over time. IgG levels appeared to decrease over time in ocrelizumab trials but remained relatively stable over time in ofatumumab trials. Additional research is needed to understand differences between ocrelizumab and ofatumumab and identify people at risk of decreasing IgG levels and infection.

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Ocrelizumab after natalizumab in JC-virus positive relapsing remitting multiple sclerosis patients

Cited by 11 publications

References 11 publications

Switch to ocrelizumab in MS patients treated with natalizumab in extended interval dosing at high risk of PML: A 96-week follow-up pilot study

Switch to ocrelizumab in MS patients treated with natalizumab in extended interval dosing at high risk of PML: A 96-week follow-up pilot study

Is It Time for Ocrelizumab Extended Interval Dosing in Relapsing Remitting MS? Evidence from An Italian Multicenter Experience During the COVID-19 Pandemic

Systematic literature review of immunoglobulin trends for anti-CD20 monoclonal antibodies in multiple sclerosis

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