The incidence and significance of anti-natalizumab antibodies

Calabresi, Peter A.; Giovannoni, Gavin; Confavreux, Christian; Galetta, Steven; Havrdová, Eva; Hutchinson, Michael; Kappos, Ludwig; Miller, D. H.; O’Connor, Paul; Phillips, J. Theodore; Polman, Chris H.; Radüe, Ernst Wilhelm; Rudick, RA; Stuart, William H.; Lublin, Fred; Wajgt, A; Weinstock‐Guttman, B.; Wynn, Daniel; Lynn, F; Panzara, Michael A.

doi:10.1212/01.wnl.0000277457.17420.b5

Cited by 317 publications

(262 citation statements)

References 12 publications

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“…This has been shown to happen with abciximab 178 and natalizumab 179 . In the case of abciximab, this can also lead to severe thrombocytopenia, although this is not solely due to anti-abciximab antibodies as it also occurs with small molecule α IIb β 3 antagonists 178 .…”

Section: Discussionmentioning

confidence: 97%

Integrins as therapeutic targets: lessons and opportunities

Cox

Brennan

Moran

2010

Nat Rev Drug Discov

413

350

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Section: Discussionmentioning

confidence: 97%

Integrins as therapeutic targets: lessons and opportunities

Cox

Brennan

Moran

2010

Nat Rev Drug Discov

413

350

View full text Add to dashboard Cite

“…Nonetheless, there are examples that are widely, if not universally, employed. Neutralising antibody levels for IFN 34 and for natalizumab 35 explain a proportion of poorer efficacy of these medications. More generally, T2 lesion increases and brain volume reduction on treatment are predictive of longer term clinical efficacy, at least at a group level.…”

Section: Personalised Medicine For Multiple Sclerosis: Is It Needed?mentioning

confidence: 99%

Personalised medicine for multiple sclerosis care

2016

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Treatments with a range of efficacy and risk of adverse events have become available for the management of multiple sclerosis (MS). However, now the heterogeneity of clinical expression and responses to treatment pose major challenges to improving patient care. Selecting and managing the drug best balancing benefit and risk demands a new focus on the individual patient. Personalised medicine for MS is based on improving the precision of diagnosis for each patient in order to capture prognosis and provide an evidence-based framework for predicting treatment response and personalising patient monitoring. It involves development of predictive models involving the integration of clinical and biological data with an understanding of the impact of disease on the lives of individual patients. Here, we provide a brief, selective review of challenges to personalisation of the management of MS and suggest an agenda for stakeholder engagement and research to address them.

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“…In another phase II singledose trial, O'Connor et al [2004] could not observe such a rebound effect. Although neutralizing antibodies decreased the clinical and MRI benefit of natalizumab, there was no rebound phenomenon in the pivotal phase III trials [Calabresi et al 2007]. Vellinga et al [2008] found that lesion activity increased after cessation of treatment and almost only in patients who received up to eight infusions.…”

Section: Natalizumab Treatment Guidelinesmentioning

confidence: 99%

“…In patients with persistent anti-natalizumab antibodies the level of natalizumab remains below the limit of quantification. Owing to high therapy costs and near loss of efficacy in persistently antibodypositive individuals [Calabresi et al 2007], antibody testing is justified in every patient receiving natalizumab. The antibody testing should be repeated after 2-3 months.…”

Section: Anti-natalizumab Antibodiesmentioning

confidence: 99%

Review: Natalizumab in the treatment of multiple sclerosis

Yaldizli

Putzki

2009

Ther Adv Neurol Disord

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Natalizumab reduced the rate of clinical relapse at one year by 68% and the risk of sustained progression of disability by 42-54% over 2 years in its pivotal phase III trial (AFFIRM) in relapsing-remitting multiple sclerosis (RRMS). Natalizumab is generally well tolerated, but due to rare and potentially fatal side-effects, it was approved with a restricted-distribution format in 2006. Expert statements and the European Medical Agency recommend the use of natalizumab after failure of first-line disease-modifying therapies in patients with relapsing forms of MS. As part of the risk management plan, worldwide extensive safety programmes aim to provide more data on natalizumab safety in clinical practice. At the end of September 2008, 48 000 patients have received natalizumab and 18 000 patients are on treatment for at least 1 year. The assessment of risk and benefit is still ongoing.

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The incidence and significance of anti-natalizumab antibodies

Abstract: The incidence of persistent antibody positivity associated with natalizumab is 6%. Reduced clinical efficacy is apparent in persistently positive patients. Patients with a suboptimal clinical response or persistent infusion-related adverse events should be considered for antibody testing.

Cited by 317 publications

References 12 publications

Integrins as therapeutic targets: lessons and opportunities

Integrins as therapeutic targets: lessons and opportunities

Personalised medicine for multiple sclerosis care

Review: Natalizumab in the treatment of multiple sclerosis

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