TY - JOUR
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 - Romme Christensen, Jeppe
AU - Bramow, Stephan
AU - Sellebjerg, Finn
AU - Sejbaek, Tobias
N1 - Publisher Copyright:
© The Author(s), 2024.
PY - 2024/6
Y1 - 2024/6
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.
KW - anti-CD20
KW - biomarkers
KW - extended dosing
KW - Multiple sclerosis
KW - NEDA-3
KW - neuroimaging
KW - ocrelizumab
KW - personalized medicine
KW - treatment interval
UR - http://www.scopus.com/inward/record.url?scp=85192384800&partnerID=8YFLogxK
U2 - 10.1177/13524585241245296
DO - 10.1177/13524585241245296
M3 - Journal article
C2 - 38646949
AN - SCOPUS:85192384800
SN - 1352-4585
VL - 30
SP - 847
EP - 856
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 7
ER -