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ABN Abstracts 2022
Poster presentations
136 NOVA primary results randomised controlled study of natalizumab Q6W versus continued Q4W treatment for MS
  1. John Foley1,
  2. Gilles Defer2,
  3. Lana Zhovtis Ryerson3,
  4. Jeffrey Cohen4,
  5. Douglas Arnold5,
  6. Helmut Butzkueven6,
  7. Gary Cutter7,
  8. Gavin Giovannoni8,
  9. Joep Killestein9
  1. 1Rocky Mountain MS Clinic, Salt Lake City, UT, USA
  2. 2Centre Hospitalier Universitaire de Caen, Caen, France
  3. 3Department of Neurology, NYU Langone Health, New York University, New York, NY, USA
  4. 4Cleveland Clinic, Cleveland, OH, USA
  5. 5McGill University, and NeuroRx Research, Montreal, QC, Canada
  6. 6Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia
  7. 7University of Alabama School of Public Health, Birmingham, AL, USA
  8. 8Barts and The London School of Medicine and Dentistry
  9. 9MS Centre Amsterdam, VU University Medical Centre, Amsterdam, Netherlands

Abstract

Background Natalizumab every-6-week (Q6W) dosing is associated with lower progressive multifocal leukoencephalopathy risk than every-4-week dosing (Q4W) in retrospective analyses. NOVA is the first randomised trial to assess Q6W efficacy.

Objective Evaluate natalizumab Q6W efficacy in patients previously treated with natalizumab Q4W for

≥12 months compared with continuation of Q4W over 72 weeks.

Methods NOVA is a randomised, controlled, open-label, rater-blinded phase 3b trial. Included patients were treated with natalizumab Q4W without relapse for ≥12 months. Patients were randomised 1:1 to Q4W (n=248) or Q6W (n=251). The primary endpoint was new/newly enlarging T2 (N/NET2) lesions. Secondary endpoints included clinical and safety outcomes.

Results Proportions of patients with N/NET2 lesions were low in both arms (Q4W:4.1%; Q6W:4.3%). Differ- ences in mean N/NET2 lesions for Q4W and Q6W (primary estimand: 0.05 vs 0.20 [P=0.0755]; secondary estimand: 0.06 vs 0.31 [P=0.0437]) were driven by two Q6W patients with extreme (≥25) values. Secondary outcomes were similar for Q4W and Q6W.

Conclusions Overall, NOVA data suggest most patients stable on natalizumab Q4W can switch to Q6W without clinically meaningful loss of efficacy. Support: Biogen. Disclosures on poster.

https://doi.org/10.1136/jnnp-2022-abn2.180

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