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EAN 2022 | NEXT-MS: personalized extended interval dosing of natalizumab in RRMS

Alyssa Toorop, MD, PhD, Amsterdam University Medical Center, Amsterdam, The Netherlands, discusses the NEXT-MS (NCT04225312) clinical trial evaluating the feasibility and validating the efficacy of personalized extended interval dosing (EID) of natalizumab based on individual drug concentrations in patients with relapsing-remitting multiple sclerosis (RRMS). The study has three groups: personalized treatment with the aim of a natalizumab trough concentration of 5µg/ml (EID5), natalizumab trough concentration of 10µg/ml (EID10), and a standard interval dosing group. The treatment intervals are determined after two consecutive measures of natalizumab drug concentrations, and additional weeks are added to the current treatment interval. The preliminary results show that most patients in the EID5 group can extend to a 6-week interval between infusions, with one-third of patients being able to extend beyond six weeks. In the EID10 group, the majority of patients can extend to five weeks between infusions. Importantly, no differences in radiological and clinical disease activity have been observed between extended and standard interval dosing groups. This interview took place at the European Academy of Neurology (EAN) 2022 Congress in Vienna, Austria.

Transcript (edited for clarity)

The NEXT-MS study is a study about personalized extended dosing of natalizumab. Natalizumab is a very effective therapy for patients with relapsing-remitting MS. However, in 85% of patients, natalizumab direct concentrations are still very high in the standard treatment interval of every four weeks. Several research groups studied extended interval dosing, and they found equally effective suppression of disease activity compared to standard interval dosing, so when the treatment intervals are extended with longer amount of weeks between infusions...

The NEXT-MS study is a study about personalized extended dosing of natalizumab. Natalizumab is a very effective therapy for patients with relapsing-remitting MS. However, in 85% of patients, natalizumab direct concentrations are still very high in the standard treatment interval of every four weeks. Several research groups studied extended interval dosing, and they found equally effective suppression of disease activity compared to standard interval dosing, so when the treatment intervals are extended with longer amount of weeks between infusions. But the natalizumab drug concentrations, they also vary widely between patients, so a personalized approach might be superior to fixed extended intervals. Therefore, the aim of the NEXT-MS study is to study personalized extended interval dosing based on those trough concentrations.

It’s a national multicenter prospective study, in which patients with relapsing-remitting MS can participate in three different study groups: a study group with an aim trough concentration of 5µg/ml, an aim of 10µg/ml, and a standard interval dosing group. The treatments intervals are then determined after two consecutive measures of the natalizumab drug concentrations, and additional weeks are then added to the current treatment interval. The primary outcome of the study is radiological disease activity defined by new or enlarged lesions on MRI.

The preliminary results of our studies show that in the EID-5 group, the majority of patients can extend to a six-week interval between infusions, but about one-third of patients can even extend beyond six weeks, so seven to nine weeks, and some even up to nine weeks. And in the EID-10 group, the majority of patients can extend to five weeks between infusions, and up until now, we do not see any differences in radiological and clinical disease activity. There were also no cases of PML, so potential complications. We think that this is a potential way to implement personalized dosing into clinical care.

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