Extended interval dosing with ocrelizumab in multiple sclerosis
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Extended interval dosing with ocrelizumab in multiple sclerosis. / Novak, Frederik; Bajwa, Hamza Mahmood; Østergaard, Kamilla; Berg, Jonas Munksgaard; Madsen, Jonna Skov; Olsen, Dorte Aalund; Urbonaviciute, Inga; Illes, Zsolt; Stilund, Morten Leif; Christensen, Jeppe Romme; Bramow, Stephan; Sellebjerg, Finn; Sejbaek, Tobias.
I: Multiple Sclerosis Journal, 22.04.2024.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Extended interval dosing with ocrelizumab in multiple sclerosis
AU - Novak, Frederik
AU - Bajwa, Hamza Mahmood
AU - Østergaard, Kamilla
AU - Berg, Jonas Munksgaard
AU - Madsen, Jonna Skov
AU - Olsen, Dorte Aalund
AU - Urbonaviciute, Inga
AU - Illes, Zsolt
AU - Stilund, Morten Leif
AU - Christensen, Jeppe Romme
AU - Bramow, Stephan
AU - Sellebjerg, Finn
AU - Sejbaek, Tobias
PY - 2024/4/22
Y1 - 2024/4/22
N2 - BACKGROUND: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS).METHODS: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint.RESULTS: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells.CONCLUSION: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.
AB - BACKGROUND: This study investigates clinical and biomarker differences between standard interval dosing (SID) and extended interval dosing (EID) of ocrelizumab therapy in multiple sclerosis (MS).METHODS: This is a prospective, double-arm, open-label, multi-center study in Denmark. Participants diagnosed with MS on ocrelizumab therapy >12 months were included (n = 184). Clinical, radiological, and blood-based biomarker outcomes were evaluated. MRI disease activity, relapses, worsening of neurostatus, and No Evidence of Disease Activity-3 (NEDA-3) were used as a combined endpoint.RESULTS: Out of 184 participants, 107 participants received EID (58.2%), whereas 77 participants received SID (41.8%). The average extension was 9 weeks with a maximum of 78 weeks. When comparing EID to SID, we found higher levels of B-cells, lower serum concentrations of ocrelizumab, and similar levels of age-adjusted NFL and GFAP in the two groups. No difference in NEDA-3 between EID and SID was demonstrated (hazard ratio: 1.174, p = 0.69). Higher levels of NFL were identified in participants with disease activity. Body mass index correlated with levels of ocrelizumab and B-cells.CONCLUSION: Extending one treatment interval of ocrelizumab on average 9 weeks and up to 78 weeks did not result in clinical, radiological, or biomarker evidence of worsening compared with SID.
U2 - 10.1177/13524585241245296
DO - 10.1177/13524585241245296
M3 - Journal article
C2 - 38646949
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
SN - 1352-4585
ER -
ID: 390174248