TY - JOUR
T1 - Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis
AU - Chisari, Clara Grazia
AU - Grimaldi, Luigi Maria
AU - Salemi, Giuseppe
AU - Ragonese, Paolo
AU - Iaffaldano, Pietro
AU - Bonavita, Simona
AU - Sparaco, Maddalena
AU - Rovaris, Marco
AU - D'Arma, Alessia
AU - Lugaresi, Alessandra
AU - Ferrò, Maria Teresa
AU - Grossi, Paola
AU - DI Sapio, Alessia
AU - Cocco, Eleonora
AU - Granella, Franco
AU - Curti, Erica
AU - Lepore, Vito
AU - Trojano, Maria
AU - Patti, Francesco
N1 - Publisher Copyright:
© 2020 BMJ Publishing Group. All rights reserved.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Introduction 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. Materials and methods 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. Results 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. Discussion 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.
AB - Introduction 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. Materials and methods 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. Results 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. Discussion 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.
UR - http://www.scopus.com/inward/record.url?scp=85094192975&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85094192975&partnerID=8YFLogxK
U2 - 10.1136/jnnp-2020-323472
DO - 10.1136/jnnp-2020-323472
M3 - Article
C2 - 33055141
AN - SCOPUS:85094192975
VL - 91
SP - 1297
EP - 1303
JO - Journal of Neurology, Neurosurgery and Psychiatry
JF - Journal of Neurology, Neurosurgery and Psychiatry
SN - 0022-3050
IS - 12
ER -