Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis.

Natalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population. This retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the 'Italian MS Register'. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions on average from 28 to 32 days (median 30) and extended interval dosing (EID) including patients who have been infused with interval between 33 and 49 days (median 43). Clinical data were assessed at baseline (before starting NTZ), after 12 (T1) and 24 months (T2) of treatment. Out of 5231 patients with RR-MS screened, 2092 (mean age 43.2±12.0, 60.6% women) were enrolled. A total of 1254 (59.9%) received NTZ according to SID, and 838 (40.1%) according to EID. At 12 and 24 months, no differences in terms of annualised relapse rate and disability status were found between the two groups. Progression index and confirmed disability worsening were similar between the two groups. The use of NTZ with an extended interval schedule showed similar effectiveness compared with SID. Unchanged clinical efficacy of EID schedule may raise the question of a possible advantage in terms of tolerability and safety.

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Competing interests: CGC has received grants for congress participation from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme and Teva. GS received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. PR has received grants for speaking activities from Biogen, Merck Serono, Novartis, TEVA and grants for congress participation from Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA. LMG received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. SB received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. AL received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. MTF received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. ElC received speaker’s honoraria, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. FG received honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. MT received speaker’s honoraria, consulting fees, honoraria in advisory boards, support for attendance of scientific meetings from Meck Serono, Biogen, Novartis, Teva and Sanofi Genzyme. FP has received honoraria for speaking activities by Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA; he also served as advisory board member the following companies: Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA; he was also funded by Pfizer and FISM for epidemiological studies; he received grants for congress participation from Almirall, Bayer Shering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Genzyme and TEVA.