Clinical relevance of natalizumab tests for multiple sclerosis
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1 Clinical relevance of natalizumab tests for multiple sclerosis Theo Rispens
2 Multiple Sclerosis
3 Treatment of (relapsing-remitting) MS 1 st line IFN-β (Avonex, Rebif, Betaferon) Glatiramer acetate (Copaxone) 2 nd line natalizumab (Tysabri) fingolimod (Gilenya)
4 Natalizumab is effective treatment of relapsingremitting MS
5 Natalizumab natalizumab is an effective drug, but: expensive can be immunogenic associated with rare but life-threatening side effects
6 Natalizumab IgG4 antibody Directed against a4-integrin (VLA-4) Interferes with lymphocyte migration across blood-brain barrier Y. Yu et al. JBC 2013
7 Fab arm exchange: Natalizumab: IgG4 + anti-lambda natalizumab x serum IgG4 VLA-4 Labrijn et al. Nature Biotechnol. 2009
8 Measurement of natalizumab levels -bt natalizumab rab. antinatalizumab 3 2 OD IgG (ng/ml) Rispens et al., Anal Biochem 2011
9 Measurement of natalizumab levels II -bt -bt rab. anti-natalizumab anti-igg4 natalizumab serum IgG4 I II Background signals: Fc-Fc binding (I): -bt 2 I II OD 1 Eliminated using anti-idiotype F(ab )2 (II) 0 Rab IgG Rab Fab2 Rispens et al. J Immunol 2009; Rispens et al., Anal Biochem 2011
10 Measurement of natalizumab levels II rab. anti-natalizumab anti-igg4 natalizumab serum IgG4 -bt OD IgG (ng/ml) Rispens et al., Anal Biochem 2011
11 Measurement of natalizumab levels II 100 natalizumab (mg/l) Rispens et al., Anal Biochem 2011
12 Clinical relevance of natalizumab concentration Vennegoor et al., Mult. Sclerosis 2013
13 natalizumab: clinic vs PK low serum natalizumab concentrations (< 1 μg/ml): 14.5 higher odds ratio to develop Gd+ lesions (95% CI , p=0.006) 9.0 higher odds ratio to have a relapse (95% CI , p=0.01) Vennegoor et al., Mult. Sclerosis 2013
14 Anti-drug antibodies (ADA) to natalizumab assays: bridging elisa (drug-sensitive) antigen binding test (drug tolerant) natalizumab-bt 125 I natalizumab F(ab )2 ADA natalizumab protein A Sepharose ADA
15 Antibodies to natalizumab at 12, 24, and 52 weeks Vennegoor et al., Mult. Sclerosis 2013
16 correlation between anti-natalizumab antibodies and serum natalizumab concentration at week 24 (Spearman s Rho 0.765, p<0.001) Vennegoor et al., Mult. Sclerosis 2013
17 natalizumab: clinic vs ADA Vennegoor et al., Mult. Sclerosis 2013
18 natalizumab: ADA vs PK in time naive patients Unpublished data available upon request
19 natalizumab: ADA vs PK in time patients > 6 months Unpublished data available upon request (t.rispens@sanquin.nl)
20 antibodies to natalizumab: assay issues Study ADA incidence Calabresi et al. neurology % Lundkvist et al. mult. sclerosis % Oliver-Martos et al. J. neurology % Vennegoor et al. mult. sclerosis % reported incidences of ADA vary widely due in part to differences in assay technology in general, ADA assays difficult to standardize measurement of drug levels circumvents this problem
21 Natalizumab and PML Progressive multifocal leucoencephalopathy (PML) is an opportunistic demyelating brain disease Caused by JC virus Ca % of the general population is infected Impaired cellular immunity, including natalizumab treatment, is accociated with PML Total reported cases of PML (Mar 2014): 439 Total deceased: 99
22 Natalizumab and PML Table 1: Estimated PML Incidence Stratified by Risk Factor Tysabri Exposure Anti-JCV Antibody Positive* No Prior Immunosuppressant Use Anti-JCV Antibody Positive* Prior Immunosuppressant Use 1-24 months <1/1,000 2/1, months 4/1,000 11/1,000
23 Natalizumab and PML Natalizumab has half-life of ca. 11 days to restore leucocyte transmigratory capacity swiftly, natalizumab levels can be decreased using plasma exchange (PLEX) (Khatri et al. Neurology 2009)
24 A serum natalizumab concentration below 1 μg/ml results in VLA-4 desaturation Khatri et al., neurology 2009
25 Monitoring natalizumab concentrations during plasma exchange (PLEX) Efficiency of PLEX varies between patients Monitoring of natalizumab concentrations can aid in optimizing PLEX Unpublished data available upon request
26 Conclusions Natalizumab concentrations correlate with relapse and are inversely correlated with antibodies to natalizumab Many patients make antibodies; in many cases, antibody formation is transient Measurement of natalizumab concentrations can be a tool to optimize treatment of MS patients Monitoring natalizumab concentrations can help to optimize treatment intervention during PML
27 Acknowledments Sanquin Diagnostics Desiree van der Kleij Tjitske van Palen-Merkus Astrid van Leeuwen Steven Stapel Sanquin Research Rob Aalberse Simone Kruithof Margreet Hart Lucien Aarden Gertjan Wolbink VuMC Anke Vennegoor Joep Killestein
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