Details

Autor(en) / Beteiligte

• Pelle, Juliette
• Briant, Anais R.
• Branger, Pierre
• Derache, Nathalie
• Arnaud, Charlotte
• Lebrun-Frenay, Christine
• Cohen, Mikael
• Mondot, Lydiane
• De Seze, Jerome
• Bigaut, Kevin
• Collongues, Nicolas
• Kremer, Laurent
• Ricard, Damien
• Bompaire, Flavie
• Ohlmann, Charlotte
• Sallansonnet-Froment, Magali
• Ciron, Jonathan
• Biotti, Damien
• Pignolet, Beatrice
• Parienti, Jean-Jacques
• Defer, Gilles

Titel

Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

Ist Teil von

• Neurology and therapy, 2023-04, Vol.12 (2), p.529-542

Ort / Verlag

Cheshire: Springer Healthcare

Erscheinungsjahr

2023

Quelle

Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals

Beschreibungen/Notizen

• Introduction Natalizumab, a therapy for relapsing–remitting multiple sclerosis (RRMS), is associated with a risk of progressive multifocal leukoencephalopathy (PML). Over the last several years, practitioners have used off-label extended interval dosing (EID) of natalizumab to reduce PML risk, despite the absence of a large-scale efficacy evaluation. Methods We conducted a retrospective, multicenter cohort study among adults with RRMS receiving stable standard interval dosing (SID), defined as a ≥ 12-month consecutive period of ≥ 11 natalizumab infusions/year in France. We compared the 12-month risk difference of remaining relapse-free (primary endpoint) between patients who switched to EID (≤ 9 natalizumab infusions) and those who remained on SID, with a noninferiority margin of − 11%. We used propensity score methods such as inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM). Secondary endpoints were annualized relapse rate, disease progression, and safety. Results Baseline characteristics were similar between patients receiving EID ( n  = 147) and SID ( n  = 156). The proportion of relapse-free patients 12 months postbaseline was 142/147 in the EID (96.6%) and 144/156 in the SID group (92.3%); risk difference (95% CI) 4.3% (− 1.3 to 9.8%); p  < 0.001 for non-inferiority. There were no significant differences between relapse rates (0.043 vs. 0.083 per year, respectively; p  = 0.14) or Expanded Disability Status Scale mean scores (2.43 vs. 2.72, respectively; p  = 0.18); anti-JC virus index values were similar ( p  = 0.23); and no instances of PML were reported. The comparisons using IPTW ( n  = 306) and PSM ( n  = 204) were consistent. Conclusion These results support the pertinence of using an EID strategy for RRMS patients treated with natalizumab. Clinical Trials gov identifier (NCT04580381).