TY - JOUR
T1 - Shortening the washout to 4 weeks when switching from natalizumab to fingolimod and risk of disease reactivation in multiple sclerosis
AU - Naegelin, Y.
AU - Rasenack, M.
AU - Andelova, M.
AU - Von Felten, S.
AU - Fischer-Barnicol, B.
AU - Amann, M.
AU - Mehling, M.
AU - Kappos, L.
AU - Sprenger, T.
AU - Derfuss, T.
N1 - Publisher Copyright:
© 2018 The Author(s)
PY - 2018/10
Y1 - 2018/10
N2 - BACKGROUND: There is limited evidence about the optimal length of washout when switching from natalizumab to fingolimod. OBJECTIVE: To study if a washout period of 4 weeks is associated with less disease activity compared to 8 weeks. METHODS: 25 patients with Relapsing Remitting Multiple Sclerosis were included in an open label, prospective study with a follow-up of 108 weeks. The primary endpoint (PE) was defined as “time to first relapse or MRI disease activity up to week 56”. In addition, a recurrent event analysis (REA) was performed up to week 108. RESULTS: The PE was not met (HR 0.67, 95% CI [0.22,1.97], p = 0.462). Number of relapses before stopping natalizumab was positively associated with the hazard of relapse (HR 3.91, p = 0.0117, 95% CI [1.36, 11.28]). The REA showed a reduction of the hazard to develop a relapse by 77% (HR 0.23, 95% CI [0.08, 0.69], p = 0.00854) in favor of the cohort with 4 weeks washout. CONCLUSIONS: Our study suggests that switching from natalizumab to fingolimod with a shorter washout of 4 weeks might reduce the risk of disease reactivation after switching.
AB - BACKGROUND: There is limited evidence about the optimal length of washout when switching from natalizumab to fingolimod. OBJECTIVE: To study if a washout period of 4 weeks is associated with less disease activity compared to 8 weeks. METHODS: 25 patients with Relapsing Remitting Multiple Sclerosis were included in an open label, prospective study with a follow-up of 108 weeks. The primary endpoint (PE) was defined as “time to first relapse or MRI disease activity up to week 56”. In addition, a recurrent event analysis (REA) was performed up to week 108. RESULTS: The PE was not met (HR 0.67, 95% CI [0.22,1.97], p = 0.462). Number of relapses before stopping natalizumab was positively associated with the hazard of relapse (HR 3.91, p = 0.0117, 95% CI [1.36, 11.28]). The REA showed a reduction of the hazard to develop a relapse by 77% (HR 0.23, 95% CI [0.08, 0.69], p = 0.00854) in favor of the cohort with 4 weeks washout. CONCLUSIONS: Our study suggests that switching from natalizumab to fingolimod with a shorter washout of 4 weeks might reduce the risk of disease reactivation after switching.
KW - Disease modifying drugs
KW - Drug Switching
KW - Fingolimod
KW - Immunomodulation
KW - Multiple sclerosis
KW - Natalizumab
UR - http://www.scopus.com/inward/record.url?scp=85049749946&partnerID=8YFLogxK
U2 - 10.1016/j.msard.2018.07.005
DO - 10.1016/j.msard.2018.07.005
M3 - Article
C2 - 30014876
AN - SCOPUS:85049749946
SN - 2211-0348
VL - 25
SP - 14
EP - 20
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
ER -