Frequency of adverse events associated with intravenous immunoglobulin therapy in patients with pemphigus or pemphigoid.

BACKGROUND: Intravenous immunoglobulin (IVIG) therapy is widely used in immune-mediated diseases as an immunomodulatory agent and is considered to be a safe biologic agent.

OBJECTIVE: To determine the frequency of adverse events associated with IVIG therapy in patients with pemphigus and pemphigoid.

METHODS: We retrospectively reviewed data on patients treated with IVIG for pemphigus and pemphigoid over a 10 year period. Patients had pemphigus vulgaris, pemphigus foliaceus, mucous membrane pemphigoid, or bullous pemphigoid. IVIG was given according to a published protocol at a dose of 2 g/kg administered over 3-5 days at prescribed intervals. Patient records were reviewed for information on sex, age, duration of treatment, number of cycles given, number of days each patient received IVIG, weight of each patient, IVIG dose each patient received per infusion, and early or delayed adverse effects reported by patients or observed by healthcare providers.

RESULTS: We identified 9892 infusions given to 174 patients. Headaches were the most common adverse effects; they were observed during 886 (8.9%) infusions and involved 123 (70.6%) patients. The incidence of other minor adverse effects, including fatigue, nausea, vomiting, chills, urticaria, swollen glands, hoarseness, thoracic discomfort, and palpitations, was 0.57-3.4% per infusion and 0.04-1.3% per patient. Hoarseness of voice and swelling of cervical lymph nodes have not been previously reported. Acute renal failure occurred in one patient and was the only major adverse effect observed. None of the patients required hospitalization, and there were no deaths.

CONCLUSIONS: Adverse events associated with IVIG therapy are usually mild and self-limiting. The incidence of serious adverse events is low. Identification of risk factors and close monitoring of high-risk patients throughout the therapy are likely to decrease the occurrence of rare serious and less likely fatal adverse effects.