Evaluación de la efectividad y la seguridad del natalizumab en el tratamiento de la esclerosis múltiple remitente recidivante

Fernández-Megía, María José; Casanova, Bonaventura; Magraner, M.J.; Font-Noguera, I.; Poveda‐Andrés, José Luis

doi:10.1016/j.farma.2010.02.003

Cited by 9 publications

(3 citation statements)

References 6 publications

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“…Regarding disability, we observed that the decrease in EDSS score was greater than what was reported in Europe 21,26,30 , but lower than the results achieved in a study in Kuwait 34 . In addition, observational studies 7,26,27,28,29,30,31,32,33,34,35 have reported that between 9 and 57% of PwRMS experienced improvement of disability, while 4-17% had worsening of disability, which is consistent with our results. In this regard, a post hoc analysis within AFFIRM reported that PwRMS treated with natalizumab increased their cumulative likelihood of 12-week confirmed improvement of disability, compared with placebo at two years 36 .…”

Section: Discussionsupporting

confidence: 92%

“…In the present study, we observed that treatment with natalizumab significantly reduced the number of relapses at one and two years (93.9 and 92.9%, respectively). This was comparable with the 90.7% reduction in ARR achieved in TOP 32 and 83.2% in a recently published study in the US 6 , as well as in other observational studies 14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31 . In addition, the TOP study reported that PwRMS treated with natalizumab presented associations with reductions in relapse-related hospitalizations and steroid treatment, despite longer follow-up in the on-natalizumab period than in the pre-natalizumab period 33 .…”

Section: Discussionsupporting

confidence: 90%

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Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile

Ysrraelit

Caride

Sinay

et al. 2021

Arq. Neuro-Psiquiatr.

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Background: The real-world effectiveness of natalizumab in people with relapsing multiple sclerosis (PwRMS) in Argentina and Chile has not been reported. Objective: To evaluate the effectiveness of natalizumab treatment in PwRMS in Argentina and Chile, in clinical practice. Methods: We conducted a multicenter retrospective and observational study. We reviewed the medical records of PwRMS who had been treated with natalizumab for at least one year, without any interruption in MS treatment that lasted more than 12 weeks. We analyzed changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score and magnetic resonance imaging (MRI). Results: We enrolled 117 PwRMS treated with natalizumab. Natalizumab treatment was associated with a significant reduction in ARR from baseline after one year and two years of treatment (from 1.97 to 0.06 and 0.09 respectively; p<0.01 at each time point). From baseline, EDSS scores were reduced by 0.71 and 0.73 points at one and two years, respectively (p<0.01). No worsening of disability was observed in 82.9 and 67.5% of PwRMS at one and two years, respectively. The improvement in disability was 44.4% at one year and 39.3% at two years. During natalizumab treatment, the number of relapse-related hospitalizations was significantly reduced (p<0.01). MRI lesions (new/enlarging T2 or gadolinium-enhancing) were significantly reduced, compared with baseline. No evidence of disease activity was observed in 65% at two years of natalizumab treatment. Conclusions: Natalizumab significantly reduced disease activity in PwRMS in Argentina and Chile, in clinical practice. Natalizumab also decreased the number of hospitalizations compared with pre-natalizumab treatment.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 90%

Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile

Ysrraelit

Caride

Sinay

et al. 2021

Arq. Neuro-Psiquiatr.

View full text Add to dashboard Cite

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“…Most published studies on this topic are descriptive [5,7,10-16]. Few research papers have attempted to correlate baseline data with outcome towards prediction of treatment response, and results are not always consistent between studies, possibly due to the methodological biases that might affect uncontrolled longitudinal studies.…”

Section: Discussionmentioning

confidence: 99%

Clinical baseline factors predict response to natalizumab: their usefulness in patient selection

Laroni

Gandoglia

Solaro³

et al. 2014

BMC Neurol

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BackgroundOptimal patient selection would improve the risk-benefit ratio of natalizumab treatment for relapsing-remitting multiple sclerosis (RR MS). Clinical features of subjects responding to natalizumab have not been univocally recognized.MethodsLongitudinal data on RR MS patients treated with natalizumab in Liguria, Italy are reported. Predictors of relapse occurrence and disability improvement were analyzed with a logistic regression method in subjects treated for one year (N = 62). A new score, called “Better EDSS Trend (BET)”, was devised to describe the impact of the treatment on disability. Changes in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) after one and two years and proportion of disease-free patients were evaluated.ResultsPrevious EDSS worsening plus ARR ≥ 2 increased the risk of relapse during the treatment [Odds Ratio (OR) 4.12, P = 0.04], but this was not associated with an increase in disability at one year. EDSS 3.0-3.5 or high disease activity were associated with neurological improvement in the first year of treatment (respectively OR 5.78, P = 0.05 and OR 4.80, P = 0.05). Positive BET score, i.e. improvement in the disability trend, was observed in 40.3% of patients, and correlated with high ARR in the year before treatment (OR 1.69, P = 0.03).ConclusionSubjects with EDSS 3.0-3.5 and those with very active disease in the year before treatment are most likely to improve in neurological function under natalizumab. A relapse in the first year of treatment is associated to high pre-treatment disease activity; however, since the occurrence of a relapse did not have a negative impact on clinical improvement at one year, we suggest that it should not lead to treatment discontinuation. We propose BET as an additional endpoint of treatment response in MS.

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Cutaneous Manifestations of Reactions to Biologics

Otani

Levin

Banerji

2018

Curr Allergy Asthma Rep

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Anti-TNF agents and immune checkpoint inhibitors have significant, immune-mediated cutaneous manifestations that can necessitate discontinuation. Anti-TNF agents, IL-6 inhibitors, and IL-12/23 inhibitors can paradoxically cause psoriasis flares or unmask previously undiagnosed psoriasis. IL-17 inhibitors are unique in increasing risk for Candida infections. Benign injection site reactions, non-specific rash, cellulitis, and hypersensitivity reactions are relatively common adverse events. A wide variety of cutaneous reactions caused by biologics have been reported, ranging from benign injection site reactions to life-threatening cutaneous reactions necessitating discontinuation of the implicated biologic agent.

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Evaluación de la efectividad y la seguridad del natalizumab en el tratamiento de la esclerosis múltiple remitente recidivante

Cited by 9 publications

References 6 publications

Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile

Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile

Clinical baseline factors predict response to natalizumab: their usefulness in patient selection

Cutaneous Manifestations of Reactions to Biologics

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