Natalizumab treatment in multiple sclerosis: the experience from two Brazilian MS centers

Oliveira, Enedina Maria Lobato de; Simm, Renata Faria; Dasic, Gorana; Morais, Marília Mamprim de; Perreira, Samira Luiza dos Apostolos; Callegaro, Dagoberto

doi:10.1590/0004-282X20150098

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Articles • Arq. Neuro-Psiquiatr. 73 (9) • Sept 2015 • https://doi.org/10.1590/0004-282X20150098 copy

Natalizumab treatment in multiple sclerosis: the experience from two Brazilian MS centers

Natalizumabe no tratamento da esclerose múltipla: a experiência de dois centros brasileiros

Authorship SCIMAGO INSTITUTIONS RANKINGS

Objective

Analyze the demographics, clinical characteristics, efficacy and safety of natalizumab treatment in Brazilian patients with multiple sclerosis (MS) followed up for at least 12 months, in two tertiary MS care centers in São Paulo.

Method

We evaluated the effect of natalizumab treatment on annualized relapse rate and disability progression in 75 patients with MS treated with natalizumab for at least 12 months. A subgroup analysis was performed to evaluate efficacy of natalizumab treatment in patients with Expanded Disability Status Scale (EDSS) ≤ 3.0 vs patients with EDSS > 3.

Results

Patients treated for at least one year with natalizumab showed a 91% reduction in aRR, as well and an improvement in neurological disability. The impact of natalizumab treatment was greater in patients with EDSS < 3.0. Overall, natalizumab was safe but one patient developed progressive multifocal leukoencephalopathy.

Conclusion

Natalizumab as a third line therapy is safe and efficacious, especially in patients with mild neurological disability.

natalizumab; multiple sclerosis; disability progression; relapse rate

Patients, n	75
Age, years
Mean ± SD	36.39 ± 8.64
Median (range)	36 (20-55)
Gender, n (%)
Male	17 (22.7)
Female	58 (77.3)
MS disease duration, years
Mean ± SD	11.84 ± 7.39
Median (range)	11 (3-42)
aRR before natalizumab
Mean ± SD	2.45 ± 1.86
Median (range)	2 (0-10)
EDSS score
Mean ± SD	4.15 ± 1.72
Median (range)	4 (1-6.5)
Progression Index
Mean ± SD	0.616 ± 0.485
Median (range)	0.469 (0-3.0)
Patients with EDSS Score ≤ 3.0, n (%)	22 (29.3)
Patients with EDSS Score > 3.0, n (%)	53 (70.7)
Previous use of immunosuppressant (IS), n (%)	40 (53.3)
Previous use of DMTs (IFNs and/or GA), n (%)
IFN and GA	50 (66.7)
IFN or GA	23 (30.7)
Neither	2 (2.7)
JCV antibody status n (%)
Negative	54 (72)
Positive	19 (25.3)
Unknown	2 (2.7)

	Before natalizumab	Over 1 year of treatment	p-values
Mean aRR	2.45 ± 1.86 (n = 75)	0.26 ± 0.58 (n = 75)	< 0.005
Mean EDSS score	4.22 ± 1.80 (n = 75)	3.56 ± 2.16 (n = 75)	< 0.005
Mean PI	0.616 ± 0.485 (n = 75)	0.367 ± 0.274 (n = 75)	< 0.005

	Before natalizumab	After natalizumab	p-values	Percentage of reduction
Mean EDSS score (baseline score ≤ 3.0)	2.0 ± 0.83 (n = 22)	1.48 ± 1.01 (n = 22)	< 0.005	26.1%
Mean EDSS score (baseline score > 3.0)	5.05 ± 1.07 (n = 53)	4.34 ± 1.53 (n = 53)	< 0.005	14.0%
Mean PI (baseline score ≤ 3.0)	0.38 ± 0.28 (n = 22)	0.19 ± 0.15 (n = 22)	< 0.005	51.1%
Mean PI (baseline score > 3.0)	0.71 ± 0.52 (n = 53)	0.44 ± 0.28 (n = 53)	< 0.005	38.0%

Reason for withdraw	n	%
PML risk*	20	57.1%
Patients’ request	6	17.1%
Vulvar Cancer	1	2.9%
Poor tolerability^§	1	2.9%
Pregnancy	1	2.9%
PML	1	2.9%
Not MS	1	2.9%
Disease stability^¥	1	2.9%
HPV uveitis	1	2.9%
PPMS	1	2.9%
SPMS	1	2.9%
Total	35	100.0%

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[1] Correspondence: Enedina Maria Lobato de Oliveira; UNIFESP / EPM, Disciplina de Neurologia; Rua Botucatu, 740; 04023-900 São Paulo SP, Brasil; E-mail:enedina.oliveira@unifesp.br