Hostname: page-component-586b7cd67f-t7czq Total loading time: 0 Render date: 2024-11-30T12:50:23.676Z Has data issue: false hasContentIssue false
  • English
  • Français

Home IVIG for CIDP: A Focus on Patient Centred Care

Published online by Cambridge University Press:  23 September 2014

Hans D. Katzberg ,
Vilija Rasutis  and
Vera Bril
Hans D. Katzberg*
Affiliation:
Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario Canada
Vilija Rasutis
Affiliation:
Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario Canada
Vera Bril
Affiliation:
Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario Canada
*
Toronto General Hospital, 200 elizabeth street, 5es-306, Toronto, Ontario, m5G 2C4, Canada. Email: [email protected]
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Objective:

To determine the safety and tolerability of home-based intravenous immunoglobulin (IVIG) (Gamunex) as maintenance treatment in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in Canada.

Methods:

We enrolled ten subjects with CIDP who had previously received IVIG in the hospital setting to receive the comparable IVIG dose (1-2 g/kg/month) in the home for six months. The patients were evaluated in the clinic at three months and at six months to evaluate their clinical status as well as the safety and tolerability of IVIG.

Results:

All subjects tolerated home-based IVIG treatment as maintenance treatment of CIDP. There were no serious adverse events related to IVIG. Subjects did experience “anticipated” IVIG events post-infusion such as headache and fatigue, which were managed with analgesics and supportive counseling. One subject withdrew consent at end of study due to hospitalization. This event was not related to the IVIG. Another subject experienced a “flare” of CIDP symptoms near the end of the study, however, completed all visits as per protocol. All subjects expressed excellent satisfaction with the individualized therapy, and almost all (nine out of ten) patients preferred home-infusion to hospital-infusion.

Conclusion:

Intravenous immunoglobulin can be delivered safely and is well tolerated outside the hospital setting in Canada in patients with chronic, stable neuromuscular conditions such as CIDP who have previously tolerated IVIG in the hospital medical day Care Unit.

Résumé:

Résumé:Objectif:

Le but de l'étude était de déterminer la sécurité et la tolérabilité de l'administration d'immunoglobuline intraveineuse (IGIV) [Gamunex] comme traitement d'entretien chez des patients atteints de polyradiculoneuropathie démyélinisante inflammatoire chronique (PdIC) au Canada.

Méthode:

Nous avons recruté 10 sujets atteints de PdIC qui avaient reçu de l'IGIV antérieurement en milieu hospitalier afin qu'ils reçoivent une dose comparable d'IGIV (1-2 g/kg/mois) à domicile pendant 6 mois. les patients étaient examinés à la clinique après 3 et 6 mois de traitement pour évaluer leur état clinique ainsi que la sécurité et la tolérabilité de l'IGIV.

Résultats:

Tous les sujets ont bien toléré le traitement à domicile par l'IGIV comme traitement d'entretien de la PdIC. Il n'y a eu aucun incident thérapeutique sérieux relié à l'IGIV. les sujets ont présenté des incidents thérapeutiques concordant avec le profil d'innocuité connu du médicament après l'infusion tels la céphalée et la fatigue qui ont été traités par des analgésiques et un counseling de soutien. Un sujet s'est retiré de l'étude à la fin de celle-ci parce qu'il a dû être hospitalisé. Cet incident n'était pas en lien avec l'IGIV. Un autre sujet a présenté une poussée de symptômes de PdIC vers la fin de l'étude. Il a cependant complété toutes les visites de suivi prévues au protocole. Tous les sujets ont témoigné d'un haut niveau de satisfaction de cette thérapie individualisée et presque tous (9 sur 10 sujets) ont préféré l'infusion à domicile plutôt qu'en milieu hospitalier.

Conclusion:

l'IGIV peut être administrée sans danger en dehors du milieu hospitalier au Canada et ce traitement est bien toléré chez les patients atteints de pathologies neuromusculaires chroniques stables telles la PdIC qui ont bien toléré l'IGIV à l'unité de jour en milieu hospitalier antérieurement.

Type
Research Article
Information
Canadian Journal of Neurological Sciences , Volume 40 , Issue 3 , May 2013 , pp. 384 - 388
Copyright
Copyright © The Canadian Journal of Neurological 2013

References

1. Hahn, AF, Bolton, CF, Zochodne, D, Feasby, TE. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyneuropathy: A double blind, placebo-controlled, crossover study. Brain. 1996;119:1067–77.Google Scholar
2. Mendell, JR, Barohn, RJ, Freimer, ML, et al. Randomized controlled trail of IVIG in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology. 2001;56:445–9.Google Scholar
3. Gamunex (Immune Globulin Intravenous [Human], 10%) [product monograph]. Mississauga (ON): Talecris Biotherapeutics Ltd.; 2012.Google Scholar
4. Sewell, WA, Brennan, VM, Donaghy, M, Chapel, HM. The use of self infused intravenous immunoglobulin home therapy in the treatment of acquired chronic demyelinating neuropathies. J Neurol Neurosurg Psychiatry. 1997;63:106–9.Google Scholar
5. Chapel, HM, Brennan, VM, Delson, E. Immunoglobulin replacement therapy by self-infusion at home. Clin Exp Immunol. 1988;73:160–2.Google Scholar
6. Danieli, MG, Pettinari, L, Moretti, R, Logullo, F, Gabrielli, A. Subcutaneous immunoglobulin in polymyositis and dermatomyositis: a novel application. Autoimmune Rev. 2011;10(3):144–9.Google Scholar
7. Lee, D, Ralf, LA, Paulus, W, Schneider-Gold, C, Chan, A, Gold, R. Subcutaneous immunoglobulin infusion: a new therapeutic option in chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2008;37:406–9.Google Scholar
8. Harbo, T, Andersen, H, Jakobsen, J. Long-term therapy with high doses of subcutaneous immunoglobulin in multifocal motor neuropathy. Neurology. 2010;75:1377–80.Google Scholar
9. Lucas, M, Hugh-Jones, K, Welby, A, Misbah, S, Spaeth, P, Chapel, H. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol. 2010;30(suppl 1):S84–9.Google Scholar
10. Batorova, A, Holme, P, Gringeri, A, et al. Continuous infusion in hemophilia: current practice in Europe. Haemophilia. 2012;18(5):1–7.Google Scholar
11. Naim, M, Hunter, J. Intravenous iron replacement - management in general practice. Aust Fam Physician. 2010; 39(11):839–41.Google ScholarPubMed
12. Souayah, N, Hasan, A, Khan, HM, Yacoub, HA, Jafri, M. The safety profile of home infusion of intravenous immunoglobulin in patients with neuroimmunologic disorders. J Clin Neuromuscul Dis. 2011;12(suppl 4):S1–10.Google Scholar
13. Kirsme, J. The nurse's role in administration of intravenous immunoglobulin therapy. Home Healthc Nurse. 2009;27(2):104–11.Google Scholar
14. Van Schaik, IN, Winer, JB, de Haan, R, Vermeulen, M. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database 2002;(2):CD 001797.Google Scholar
15. Lucas, M, Hugh-Jones, K, Welby, A, Misbah, S, Spaeth, P, Chapel, H. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol. 2010;30(suppl 1):S84–9.Google Scholar
16. Koski, CL, Baumgarten, M, Magder, LS, et al. Derivation and validation of diagnostic criteria for chronic inflammatory demyelinating polyneuropathy. J Neurol Sci. 2009;277(1-2):1–8.Google Scholar
17. Hughes, R, Bensa, S, Willison, H, et al. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 2001;50:195–201.CrossRefGoogle ScholarPubMed
18. Rigas, M, Tandan, R, Sterling, RJ. Safety of liquid intravenous immunoglobulin for neuroimmunologic disorders in the home setting: a retrospective analysis of 1085 infusions. J Clin Neuromusc Dis. 2008;10:52–5.Google Scholar
19. Dalakas, MC. Intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: present status and practical therapeutic guidelines. Muscle Nerve. 1999;22(11):1479–97.Google Scholar
20. Braine, ME, Woodall, A. A comparison between intravenous and subcutaneous immunoglobulin. Br J Nurs. 2012;21(8):S21–2, S24-7.Google Scholar
21. Brennan, VM, Cochrane, S, Fletcher, C, Hendy, D, Powell, P. Surveillance of adverse reactions in patients self-infusing intravenous immunoglobulin at home. J Clin Immunol. 1995;15:116–19.Google Scholar
22. Marano, A, Soucy, A, Krueger, A, Sanders, DB. Estimated cost of treating myasthenia gravis in an insured U. S. population. Muscle Nerve. 2012;45(3):363–6.Google Scholar
23. Beauté, J, Levy, P, Millet, V, et al. Economic evaluation of immunoglobulin replacement in patients with primary antibody deficiencies. Clin Exp Immunol. 2010;160(2):240–5.Google Scholar
24. Simoens, S. Pharmacoeconomics of immunoglobulin in primary immunodeficiency. Expert Rev Pharmacoecon Outcomes Res. 2009;9(4):375–86.Google Scholar
25. Membe, SK, Ho, C, Cimon, K, Morrison, A, Kanani, A, Roifman, CM. Economic assessment of different modalities of immunoglobulin replacement therapy. Immunol Allergy Clin N Am. 2008;28(4):861–74.Google Scholar
26. Lee, DH, Linker, RA, Paulus, W, Schneider-Gold, C, Chan, A, Gold, R. Subcutaneous immunoglobulin infusion: a new therapeutic option in chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2008;37(3):406–9.Google Scholar