Teva initiates first multiple sclerosis NAbs test study

The study has begun enrollment in approximately 130 centers across the US. It aims to study how the implementation of regularly scheduled interferon beta (IFN-beta) neutralizing antibody (NAb) tests in multiple sclerosis (MS) patients receiving high-dose IFN-beta therapy ultimately affects treatment patterns, versus the usual care of IFN-beta patients.

Previous studies have shown that the presence of IFN-beta NAbs may negatively alter the therapeutic effectiveness of the commercially available IFN-beta class of disease modifying drugs commonly used to treat MS, which includes IFN-beta-1a SC (Serono and Pfizer’s Rebif), IFN-beta-1b SC (Berlex’ Betaseron), and IFN-beta-1a IM (Biogen Idec’s Avonex). Despite the evidence that patients who develop NAbs are likely to become IFN-beta non-responders, and present an increased risk of relapses and disease progression, NAbs testing has not been a part of routine clinical practice.

Teva’s study, the NAbs Count Study, is a 12-month, randomized, controlled, open-label, parallel group study. Patients 18 years of age and older with a diagnosis of MS who have been receiving high-dose IFN-beta therapy at approved doses – either Rebif or Betaseron – continuously for at least 12 months are eligible. The study is expected to enroll approximately 2,440 subjects.

Patients will be randomized to one of two study groups. One group of patients will be scheduled for multiple IFN-beta NAb tests (up to three tests over a nine-month period) with a follow-up visit at 12 months. The other cohort of patients will be observed for 12 months under usual care conditions, which typically do not include regularly scheduled NAb tests.

As the primary endpoint of the study, researchers will evaluate the differences between study arms in the proportion of subjects whose high-dose IFN-beta therapy was changed during a 12-month follow-up period.