TY - JOUR
TI - Long-Term Effectiveness of Natalizumab in Patients with
Relapsing-Remitting Multiple Sclerosis Treated in the Routine Care in
Greece: Results from the Multicenter, Observational 5-Year Prospective
Study `TOPICS Greece'
AU - Efthimios, Dardiotis
AU - Georgios, Karachalios
AU - Antonia, Alexopoulou
AU - and Rania, Gourgioti
AU - Maria-Eleutheria, Evangelopoulos
AU - TOPICS
AU - Study Grp
JO - Clinical Drug Investigation
PY - 2021
VL - 41
TODO - 10
SP - 865-874
PB - Adis International Ltd
SN - 1173-2563
TODO - 10.1007/s40261-021-01073-y
TODO - null
TODO - Background and Objectives For chronic diseases like multiple sclerosis
(MS), real-world evidence on long-term treatment outcomes is essential.
The study aimed to provide long-term data on the safety and
effectiveness of natalizumab in patients with relapsing-remitting MS
(RRMS) treated in a routine care setting in Greece. Methods TOPICS
Greece was a multicenter, single-country, prospective 5-year
observational study. Results Between 19-Apr-2012 and 18-Dec-2014, 304
eligible adults [females: 63.2%; median age at natalizumab
initiation: 38.0 years; median disease duration: 6.2 years; median
Expanded Disability Status Scale (EDSS) score at baseline: 3.5] were
enrolled in the study by 20 hospital-based neurologists. The 1-year
annualized relapse rate (ARR) before treatment initiation was 1.859,
while the ARR during the first year of treatment was 0.131, representing
a significant 93% reduction (p < 0.001). The ARR over the median
treatment period of 59.4 months was 0.109. Patients with <= 1 relapse in
the pre-natalizumab year (46.1%) and those having received <= 1 prior
disease-modifying therapy (57.9%) displayed significantly lower
on-natalizumab ARR. The 1-, 2-, 3-, 4- and 5-year cumulative
probabilities of EDSS progression were 3.2, 6.2, 9.7, 13.4, and 17.4%,
respectively; the respective probabilities of EDSS disability
improvement were 18.3, 25.1, 27.4, 28.0, and 30.1%. Over a median
safety data collection period of 48.7 months, 4.6% of the patients
experienced >= 1 serious adverse event, with infections (reported in
1.0%) being the most common. Conclusion In real-world settings in
Greece, natalizumab displayed beneficial long-term effects on disease
activity and disability progression consistent with previous studies
with no new serious safety signals emerging.
ER -