B cell-tailored dosing of ocrelizumab shows good results

In a randomised-controlled trial, B cell-tailored dosing of ocrelizumab yielded encouraging results thus far. The interim analysis of the BLOOMS trial showed very little radiological or clinical disease activity in either the personalised interval dosing (PID) or standard interval dosing (SID) group. Final results are expected in 2027.

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, Ms Laura Hogenboom (Amsterdam University Medical Center, the Netherlands) and colleagues set up the ongoing investigator-initiated, non-inferiority BLOOMS trial (NCT05296161) [3]. The BLOOMS trial aims to recruit 296 participants; the reported interim analysis included 163 currently enrolled participants. They were required to receive ocrelizumab treatment for a minimum of 48 weeks and were randomised to PID (n=76) or SID (n=87) 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.

At the time of the interim analysis, there had been 1 relapse in each group. 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 8.0 months, the range was 6.0 to as long as 17.3 months. The drop-out percentage was 6.7% (n=11).

The final conclusions will be drawn after the full cohort of patients has completed the follow-up duration of 2 years.

1. Cucuzza CS, et al. Neurol Neuroimmunol Neuroinflamm. 2022;10(1):e200056.
2. van Lierop ZY, et al. Mult Scler. 2022;28(7):1121-25.
3. 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, 18–20 September, Copenhagen, Denmark.

 

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Posted on 18 November 202418 November 2024