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Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results.

Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S, TYSABRI Observational Program (TOP) Investigato - J. Neurol. Neurosurg. Psychiatr. (2014)

Bottom Line: Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals.Mean EDSS scores remained unchanged up to 5 years.NCT00493298.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia Department of Neurology, Box Hill Hospital, Monash University, Victoria, Victoria, Australia.

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(A) Time from first natalizumab infusion to confirmed EDSS progression in overall study population. (B) Time from first natalizumab infusion to confirmed EDSS improvement in patients with baseline EDSS scores ≥2.0. EDSS progression was defined as an increase, sustained for 6 months, of ≥0.5 points from a baseline EDSS score ≥6.0, of ≥1.0 point from a baseline EDSS score of ≥1.0 to <6.0 or of ≥1.5 points from a baseline EDSS score of 0.0. EDSS improvement was defined as a decrease, sustained for 6 months, of ≥1.0 point from baseline EDSS score. EDSS, Expanded Disability Status Scale.
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JNNP2013306936F3: (A) Time from first natalizumab infusion to confirmed EDSS progression in overall study population. (B) Time from first natalizumab infusion to confirmed EDSS improvement in patients with baseline EDSS scores ≥2.0. EDSS progression was defined as an increase, sustained for 6 months, of ≥0.5 points from a baseline EDSS score ≥6.0, of ≥1.0 point from a baseline EDSS score of ≥1.0 to <6.0 or of ≥1.5 points from a baseline EDSS score of 0.0. EDSS improvement was defined as a decrease, sustained for 6 months, of ≥1.0 point from baseline EDSS score. EDSS, Expanded Disability Status Scale.

Mentions: Using the prespecified definitions, the cumulative probability of confirmed EDSS progression at 4 and 5 years was 14%. The cumulative probability of confirmed EDSS improvement was 24% at 4 years and 27% at 5 years. Using the clinical trial definition of EDSS progression as defined above, the cumulative probability of confirmed EDSS progression at 5 years was 16% (figure 3A). The cumulative probability of improvement at 5 years in the subgroup of patients with baseline EDSS scores ≥2.06 was 29% (figure 3B). The probability of confirmed EDSS improvement was significantly higher than the probability of confirmed worsening (p<0.0001).


Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results.

Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S, TYSABRI Observational Program (TOP) Investigato - J. Neurol. Neurosurg. Psychiatr. (2014)

(A) Time from first natalizumab infusion to confirmed EDSS progression in overall study population. (B) Time from first natalizumab infusion to confirmed EDSS improvement in patients with baseline EDSS scores ≥2.0. EDSS progression was defined as an increase, sustained for 6 months, of ≥0.5 points from a baseline EDSS score ≥6.0, of ≥1.0 point from a baseline EDSS score of ≥1.0 to <6.0 or of ≥1.5 points from a baseline EDSS score of 0.0. EDSS improvement was defined as a decrease, sustained for 6 months, of ≥1.0 point from baseline EDSS score. EDSS, Expanded Disability Status Scale.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4215289&req=5

JNNP2013306936F3: (A) Time from first natalizumab infusion to confirmed EDSS progression in overall study population. (B) Time from first natalizumab infusion to confirmed EDSS improvement in patients with baseline EDSS scores ≥2.0. EDSS progression was defined as an increase, sustained for 6 months, of ≥0.5 points from a baseline EDSS score ≥6.0, of ≥1.0 point from a baseline EDSS score of ≥1.0 to <6.0 or of ≥1.5 points from a baseline EDSS score of 0.0. EDSS improvement was defined as a decrease, sustained for 6 months, of ≥1.0 point from baseline EDSS score. EDSS, Expanded Disability Status Scale.
Mentions: Using the prespecified definitions, the cumulative probability of confirmed EDSS progression at 4 and 5 years was 14%. The cumulative probability of confirmed EDSS improvement was 24% at 4 years and 27% at 5 years. Using the clinical trial definition of EDSS progression as defined above, the cumulative probability of confirmed EDSS progression at 5 years was 16% (figure 3A). The cumulative probability of improvement at 5 years in the subgroup of patients with baseline EDSS scores ≥2.06 was 29% (figure 3B). The probability of confirmed EDSS improvement was significantly higher than the probability of confirmed worsening (p<0.0001).

Bottom Line: Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals.Mean EDSS scores remained unchanged up to 5 years.NCT00493298.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia Department of Neurology, Box Hill Hospital, Monash University, Victoria, Victoria, Australia.

Show MeSH
Related in: MedlinePlus