Skip to main content
SpringerLink
Log in

Post-natalizumab clinical and radiological findings in a cohort of multiple sclerosis patients: 12-month follow-up

  • Original Article
  • Published:
Neurological Sciences Aims and scope Submit manuscript

Abstract

There is an urgent need to identify the best strategies to prevent the loss of natalizumab (N) beneficial effects after its suspension. The objective is to evaluate the clinical and radiological disease activity and to test the efficacy of immunomodulatory/immunosuppressive drugs (IT) after N suspension. Clinical and radiological data from 54 patients 2 years before treatment (pre-N), during treatment (on-N) and after interruption, during 1-year follow-up (post-N) were retrospectively collected. Annualized relapse rate (ARR), expanded disability status scale (EDSS), presence of new T2 lesions and Gd+ (gadolinium enhancing) T1 lesions were evaluated. Pre-N ARR at 1 year was 1.74 while post-N ARR was 0.94 (p = 0.0053). We observed that post-N disease activity never raised over pre-N levels, neither post-N ARR nor post-N EDSS. In patients retreated with N after suspension, post-N ARR was significantly lower than pre-N ARR (p = 0.017), but not in patients treated with other IT or in patients not treated with any disease modifying drugs (DMD). The mean time of freedom from new T2 lesions and new Gd+ lesions was lower in post-N period compared to on-N (T2 lesions p = 0.0000, Gd+ lesions p = 0.0000). In conclusion, a “rebound” pattern was not identified in our cohort, though the disease activity rapidly returned after N, regardless of the treatment used.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Polman CH, O’Connor PW, Havrdova E et al (2006) A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 354:899–910

    Article  CAS  PubMed  Google Scholar 

  2. Pucci E, Giuliani G, Solari A et al (2011) Natalizumab for relapsing remitting multiple sclerosis. Cochrane Database of Syst Rev 10:CD007621. doi:10.1002/14651858.CD007621.pub2

    Google Scholar 

  3. Bloomgren G, Richman S, Hotermans C et al (2012) Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med 366:1870–1880

    Article  CAS  PubMed  Google Scholar 

  4. Berger JR et al (2010) Considerations on discontinuing natalizumab. Ann Neurol 68:409–413

    Article  PubMed  Google Scholar 

  5. Killestein J, Vennegoor A, Strijbis EM et al (2010) Natalizumab drug holiday in multiple sclerosis: poorly tolerated. Ann Neurol 68:392–395

    Article  PubMed  Google Scholar 

  6. Vellinga MM, Castelijns JA, Barkhof F et al (2008) Postwithdrawal rebound increase in T2 lesional activity in natalizumab-treated MS patients. Neurology 70(13 Pt 2):1150–1151

    CAS  PubMed  Google Scholar 

  7. Miravalle A, Jensen R, Kinkel RP et al (2011) Immune reconstitution inflammatory syndrome in patients with multiple sclerosis following cessation of natalizumab therapy. Arch Neurol 68(2):186–191

    Article  PubMed  Google Scholar 

  8. Lenhard T, Biller A, Mueller W et al (2010) Immune reconstitution inflammatory syndrome after withdrawal of natalizumab? Neurology 75(9):831–833

    Article  CAS  PubMed  Google Scholar 

  9. AIFA (Agenzia Italiana del farmaco) Tysabri (Natalizumab) Determination (Determinazione/C n. 115/2006). (GU n. 292 16-12-2006)

  10. O’Connor Goodman A, Kappos L et al (2011) Disease activity return during natalizumab treatment interruption in patients with multiple sclerosis. Neurology 76(22):1858–1865

    Article  Google Scholar 

  11. Borriello G, Prosperini L, Mancinelli C et al (2012) Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study. Eur J Neurol 19(5):783–787

    Article  CAS  PubMed  Google Scholar 

  12. Hauser SL, Johnston SC (2009) Balancing risk and reward: the question of natalizumab. Ann Neurol 66(3):A7–A8

    Article  Google Scholar 

  13. Gorelik L, Lerner M, Bixler S et al (2010) Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol 68(3):295–303

    Article  PubMed  Google Scholar 

  14. Tubridy N, Behan PO, Capildeo R et al (1999) The effect of anti-alpha4 integrin antibody on brain lesion activity in MS. The UK Antegren Study Group. Neurology 53(3):466–472

    Article  CAS  PubMed  Google Scholar 

  15. Borriello G, Prosperini L, Marinelli F et al (2011) Observations during an elective interruption of natalizumab treatment: a post-marketing study. Mult Scler 17(3):372–375

    Article  CAS  PubMed  Google Scholar 

  16. Kaufman MD, Lee R, Norton HJ (2011) Course of relapsing-remitting multiple sclerosis before, during and after natalizumab. Mult Scler 17(4):490–494

    Article  PubMed  Google Scholar 

  17. Rigau V, Mania A, Béfort P et al (2012) Lethal multiple sclerosis relapse after natalizumab withdrawal. Neurology 79:2214

    Article  PubMed  Google Scholar 

  18. Fox R, Kappos L, Cree B et al (2011) Effects of a 24-week natalizumab treatment interruption on clinical and radiologic parameters of multiple sclerosis disease activity: the RESTORE study. Mult Scler 17:S509

    Google Scholar 

Download references

Acknowledgments

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Conflict of interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.

Author information

Authors and Affiliations

  1. 1 Multiple Sclerosis Centre, Department of Public Health, Clinical and Molecular Medicine, University of Cagliari, Cagliari, Italy

    Marta Melis, Eleonora Cocco, Jessica Frau, Lorena Lorefice, Giuseppe Fenu, Giancarlo Coghe & Maria Giovanna Marrosu

  2. Department of Diagnostic Imaging , Complex Unit of Radiodiagnostics, University of Cagliari, Cagliari, Italy

    Marco Mura

Authors
  1. Marta Melis
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Eleonora Cocco
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jessica Frau
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Lorena Lorefice
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Giuseppe Fenu
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Giancarlo Coghe
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Marco Mura
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Maria Giovanna Marrosu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marta Melis.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Melis, M., Cocco, E., Frau, J. et al. Post-natalizumab clinical and radiological findings in a cohort of multiple sclerosis patients: 12-month follow-up. Neurol Sci 35, 401–408 (2014). https://doi.org/10.1007/s10072-013-1527-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-013-1527-1

Keywords

Search

Navigation