Ocrelizumab and other anti-CD20 therapies are highly effective in relapsing-remitting MS, but there is a wide variety in B-cell reconstitution kinetics. Partial B-cell repopulation varies from 27 to 175 weeks after the last infusion. Cohort studies have already shown that with extended dosing intervals a low relapse rate is sustained [1,2].
To compare the efficacy of B-cell-tailored PID of ocrelizumab with SID in patients with relapsing-remitting MS, the ongoing investigator-initiated, non-inferiority BLOOMS trial (NCT05296161) was set up in the Netherlands [3]. The aim is to recruit 296 patients; the reported interim analysis included 163 participants currently enrolled. Participants are required to receive ocrelizumab treatment for a minimum of 48 weeks. They are randomised 1:1 to PID or SID of ocrelizumab. Infusions in the PID group will be extended as long as the CD19+ B-cell count remains below 0.01 109/L (10 cells/μL). The co-primary outcome is the number of participants with relapses and/or new/enlarging T2-lesions.
Of 163 participants in the interim analysis, 87 were in the SID and 76 in the PID group. There was 1 relapse in both groups. The number of participants with new/enlarged T2-lesions was 2 in the SID group and 1 in the PID group. Any evidence of disease activity was seen in 3 and 2 participants in the SID and PID groups, respectively.
The number of participants thus far with an infusion interval was 63. The median interval was 8 months, the range was 6.0 to as long as 17.3 months. The drop-out percentage was 6.7 (n=11).
Final conclusions can only be drawn after the full cohort of patients completed the follow-up duration of 2 years.
- Cucuzza CS, et al. Neurol Neuroimmunol Neuroinflamm. 2022 Nov 21;10(1):e200056.
- van Lierop ZY, et al. Mult Scler. 2022;28(7):1121-25.
- Hogenboom L, et al. B-cell tailored dosing versus standard interval dosing of ocrelizumab in relapsing-onset MS –Interim analysis of a randomized controlled trial (BLOOMS trial). Abstract O113, ECTRIMS 2024, 17–20 October 2024, Copenhagen, Denmark.
Medical writing support was provided by Michiel Tent
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