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A Retrospective Analysis of the Safety Profile of Intravenous Immunoglobulin in 1176 Patients Receiving Home Infusion Therapy

Souayah, Nizar, MD*; Pahwa, Ankit, MS; Burawski, Lauren, MA; Opila, Tamara, MPH; Sander, Howard, W., MD

Journal of Clinical Neuromuscular Disease: June 2018 - Volume 19 - Issue 4 - p 181–195
doi: 10.1097/CND.0000000000000201
Original Article

Objectives: This analysis assessed the safety of intravenous immunoglobulin (IVIg) in the treatment of patients with neuroimmunological and immunological disorders in a home-based setting.

Methods: Adverse reactions (ARs) were assessed in a retrospective review of 1176 patients receiving 28,677 home-based IVIg infusions between 1996 and 2013.

Results: Of 1176 patients, 648 (55.1%) experienced IVIg-related ARs; 536 (45.6%) were mild, 78 (6.6%) moderate, and 34 (2.9%) severe. Thirty-seven (3.1%) patients were hospitalized because of ARs; of these, headache was most common (51.4%). Mean number of ARs per patient increased from 1.4 (low dose) to 3.6 (high dose). Incidence of ARs increased from 41% in the first 5-year moving average in 2003 to 65% in 2008. The number of ARs correlated with the number of infusions (ρ = 0.24; P < 0.001) and the average IVIg dose (ρ = 0.10; P < 0.001).

Conclusions: Low- and high-dose IVIg were safe and well tolerated with a few serious ARs in patients with neuroimmunological and immunological disorders.

*Department of Neurology and Neurosciences, Rutgers New Jersey Medical School, Newark, NJ;

Innovative Research Associates, Philadelphia, PA; and

Department of Neurology, New York University School of Medicine, New York, NY.

Reprints: Nizar Souayah, MD, Department of Neurology and Neurosciences, Rutgers New Jersey Medical School, 90 Bergen St, DOC 8100, Newark, NJ 07103 (e-mail:

N. Souayah is a speaker for Grifols. H. Sander is a speaker and consultant for Grifols and Shire. The remaining authors report no conflicts of interest.

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