Effectiveness of Subcutaneous Natalizumab in Multiple Sclerosis: Real-World Evidence From a Finnish Registry Study
Author(s)
Auli Verkkoniemi-Ahola, MD, PhD1, Merja Soilu-Hänninen, MD, PhD2, Hanna Kuusisto, MD, PhD3, Katja Hassi, MSc4, Peter Oliver-Smith, MBA5, Maria Guzmán Castillo, PhD6, Heidi Loponen, PhD6.
1Helsinki University Hospital, Helsinki, Finland, 2Turku University Hospital, Turku, Finland, 3Tampere University Hospital, Tampere, Finland, 4Biogen, Espoo, Finland, 5Biogen, Arth, Switzerland, 6MedEngine Oy, Helsinki, Finland.
1Helsinki University Hospital, Helsinki, Finland, 2Turku University Hospital, Turku, Finland, 3Tampere University Hospital, Tampere, Finland, 4Biogen, Espoo, Finland, 5Biogen, Arth, Switzerland, 6MedEngine Oy, Helsinki, Finland.
OBJECTIVES: To evaluate the real-world effectiveness of subcutaneous (SC) natalizumab in patients with highly active relapsing-remitting multiple sclerosis (RRMS), including: 1) those who switched from intravenous (IV) administration, 2) those who initiated natalizumab directly with the SC formulation, and 3) subgroups based on dosing intervals.
METHODS: This retrospective registry study included adult RRMS patients who had ≥1 SC administration of natalizumab between April 2021 and October 2023. Patients were identified from electronic health records across three Finnish university hospitals. Data were supplemented with records from the Finnish MS register. Two groups were defined: 1) IV-to-SC switchers: patients with ≥1 IV natalizumab infusion prior to SC initiation; subdivided into those receiving standard interval dosing (SID: <5 weeks) and extended interval dosing (EID: ≥5 weeks) under SC treatment, 2) SC-first users: patients with no prior natalizumab use. Effectiveness was assessed by changes in annual relapse rate (ARR) and expanded disability status scale (EDSS) at 12 months post-SC initiation.
RESULTS: The study included 179 IV-to-SC switchers (median follow-up: 22.8 months) and 43 SC-first users (10.8 months). Among switchers, mean ARR was 0.10 (SD 0.28) at baseline and 0.08 (0.71) at 12 months post-SC initiation (Δ=0.02; p<0.001). In SC-first users, ARR decreased from 0.88 at baseline to 0.00 at 12 months (p<0.001). For switchers, the SID subgroup (n=83) had an ARR of 0.16 (1.0); in the EID subgroup (n=84) <3 relapses occurred, preventing ARR estimation due to privacy restrictions. EDSS scores remained stable across timepoints and groups. At 12 months, mean EDSS was 3.03 (1.73) in the SID group and 2.63 (1.50) in the EID group.
CONCLUSIONS: SC natalizumab remained effective after switching from IV. It also demonstrated significant effectiveness in SC-first users. EID did not compromise effectiveness. However, as these results are observational and descriptive in nature, no causal conclusions can be drawn.
METHODS: This retrospective registry study included adult RRMS patients who had ≥1 SC administration of natalizumab between April 2021 and October 2023. Patients were identified from electronic health records across three Finnish university hospitals. Data were supplemented with records from the Finnish MS register. Two groups were defined: 1) IV-to-SC switchers: patients with ≥1 IV natalizumab infusion prior to SC initiation; subdivided into those receiving standard interval dosing (SID: <5 weeks) and extended interval dosing (EID: ≥5 weeks) under SC treatment, 2) SC-first users: patients with no prior natalizumab use. Effectiveness was assessed by changes in annual relapse rate (ARR) and expanded disability status scale (EDSS) at 12 months post-SC initiation.
RESULTS: The study included 179 IV-to-SC switchers (median follow-up: 22.8 months) and 43 SC-first users (10.8 months). Among switchers, mean ARR was 0.10 (SD 0.28) at baseline and 0.08 (0.71) at 12 months post-SC initiation (Δ=0.02; p<0.001). In SC-first users, ARR decreased from 0.88 at baseline to 0.00 at 12 months (p<0.001). For switchers, the SID subgroup (n=83) had an ARR of 0.16 (1.0); in the EID subgroup (n=84) <3 relapses occurred, preventing ARR estimation due to privacy restrictions. EDSS scores remained stable across timepoints and groups. At 12 months, mean EDSS was 3.03 (1.73) in the SID group and 2.63 (1.50) in the EID group.
CONCLUSIONS: SC natalizumab remained effective after switching from IV. It also demonstrated significant effectiveness in SC-first users. EID did not compromise effectiveness. However, as these results are observational and descriptive in nature, no causal conclusions can be drawn.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO88
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Clinical Outcomes Assessment
Disease
Neurological Disorders