High dose subcutaneous immunoglobulin for idiopathic inflammatory myopathies and dysimmune peripheral chronic neuropathies treatment: observational study of quality of life and tolerance

Abstract

Background: In patients with autoimmune diseases who still derive benefit from high dose intravenous immunoglobulin (IVIg) treatment, some physicians resort to subcutaneous (SC) Ig as a replacement therapy. Objective: To collect quality of life (QoL) and tolerance data on SCIg in patients for whom the switch from IVIg to SCIg is essential to maintain treatment. Methods: This observational study included patients with either idiopathic inflammatory myopathies (IIM) or chronic dysimmune peripheral neuropathies (CDPN) treated with IVIg, who had been switched to SCIg administration for at least three months. The main objective was to describe the impact of SCIg on QoL after six months, using the generic Short-Form 36 questionnaire (SF-36). The secondary objectives were to evaluate SCIg tolerance and clinical efficiency. Results: Eight centres recruited 12 IIM patients and two centres recruited 11 CDPN patients. Neither the physical nor the mental health SF-36 component summaries showed any QoL deterioration during the six-month study period and all IIM and CDPN patients remained clinically stable during the same period. The most frequent adverse effects were injection site reactions (50%), cutaneous tissue disorders (18.2%), and nervous system disorders (13.6%). Two serious adverse events (myocarditis and cerebrovascular accident) occurred in two patients. Conclusion: In these rare inflammatory diseases, high dose SCIg administration (which can be home based) has no deleterious effect on patient QoL. It appears to be a safe and efficient alternative to hospital-based IVIg.

KEYWORDS:

• idiopathic inflammatory myopathies
• chronic dysimmune peripheral neuropathies
• intravenous immunoglobulin
• subcutaneous immunoglobulin
• SF-36

Acknowledgements

We thank the patients who participated in this study and the staff members who cared for them. We also thank Galien Health Publishing for providing editorial assistance funded by CSL Behring. The authors are fully responsible for content and editorial decisions for this manuscript. The authors made substantial contributions to the concept and design of the manuscript; they participated in data collection, analysis, interpretation and assembly. All authors revised the article critically for important intellectual content and have given final approval of the manuscript for submission.

Declaration of Interest

This work was supported by CSL Behring.

Eric Hachulla has received consultancy fees or research grant funding from LFB, CSL Behring and Octa Pharma.

Olivier Benveniste has received consultancy fees or research grant funding from LFB, CSL Behring.

Mohamed Hamidou has received speaking fees from LFB and CSL Behring.

Luc Mouthon has received consultancy fees or research grant funding from LFB, CSL Behring and Octapharma.

Nicolas Schleinitz has received consultancy fees or research grant funding from CSL Behring.

Pierre Lozeron has received consultancy fees from CSL Behring and research support from Octapharma and travel financial support for congresses from LFB, CSL Behring and Octapharma.

Jean-Marc Léger has received consultancy fees or research grant funding from Biogen-Idec, Baxter, CSL Behring, LFB, Novartis, Octapharma and Pfizer.

Christophe Vial has received consultancy fees or research grant funding from LFB, CSL Behring.

Karine Viala has received honoraria or research grants from LFB and CSL Behring.