Immune globulin therapy and kidney disease: Overview and screening, monitoring, and management recommendations.

PURPOSE: This report calls attention to the potential risks of diminished kidney function when administering immune globulin (IG). The goal is to increase awareness of chronic kidney disease (CKD) and kidney function impairment in patients receiving IG and provide recommendations for screening, monitoring, and management to promote risk prevention and mitigation. SUMMARY: Human IG preparations for intravenous (IVIG) or subcutaneous (SCIG) administration are the mainstay of treatment in patients with primary immunodeficiency diseases. Increasingly, IVIG at high doses (1,000 to 2,400 mg/kg) is also used as a treatment for a variety of autoimmune and inflammatory conditions. Although some autoinflammatory disorders respond to a single course of IVIG therapy, the majority of patients require long-term, regular infusions, thereby increasing the overall risks. Often, both patients and physicians treating adults with IG are unaware of underlying CKD or kidney function impairment. This lack of awareness constitutes a major risk factor for potential worsening, particularly when using high doses of IVIG. Therefore, screening of all patients for CKD and kidney function impairment before the use of IG is essential. Identification of the cause of kidney impairment is strongly encouraged, as IG therapy may need to be modified. CONCLUSION: As detailed here, there are potential risks to patients with impaired kidney function with administration of IG, particularly at high doses. Product selection, volume, route of administration, and rate of infusion may impact those with compromised kidney function. Therefore, screening of all patients for CKD and kidney function impairment before the use of IVIG and SCIG, as well as ongoing monitoring and management, is critical. As with all potential adverse drug reactions, the best approach is to prevent them.

Transient lymphadenopathy during intravenous immunoglobulin (IVIg) in a patient with pemphigus vulgaris.

This is the first case of transient cervical lymphadenopathy as an adverse event during IVIg infusion. IVIg plays a vital role in the treatment of many dermatological conditions and identification of adverse events can facilitate patient counseling.

Occurrence and Distribution of Hexavalent Chromium in Ground and Surface Waters in Cyprus.

The origin and distribution of hexavalent chromium, Cr (VI) over four seasonal cycles was investigated through a conceptual model that included three aquifer systems in Cyprus. An extensive water sampling grid covered two sea water intruded coastal aquifers, namely the Kokkinochoria (A1) and Kiti-Pervolia (A2) aquifers and the Troodos massif (A3). Analytical results give a first insight to the presence of Cr (VI) in Cyprus ground and surface waters. The highest Cr (VI) value of 26 µg L-1 is observed in the Troodos area (A3) where Cr(VI) is detected in all sampled water systems (surface and ground/spring). Nonetheless, the highest median values of 4.6 and 4.5 µg L-1 are observed in the Kokkinochoria (A1) and Kiti-Pervolia (A2) study areas respectively, where the local aquifers are under increased pressure from agriculture, urbanization and seawater intrusion. Stable isotopes were used to discern the effect of return irrigation and seawater intrusion. Stable isotope analyses from Troodos samples show two distinct groups of meteoric and near meteoric waters whereas isotopically enriched water is shown to correspond to the Kiti and Kokkinochoria area.

Rationale for including intravenous immunoglobulin in the multidrug protocol of curative treatment of pemphigus vulgaris and development of an assay predicting disease relapse.

Analysis of reported outcomes of treatment of pemphigus vulgaris (PV) patients demonstrated that the multidrug approach offers a lower relapse rate compared to the FDA-approved prednisone/rituximab regimen. The multidrug protocol protects keratinocytes from autoantibody attack by systemic corticosteroids and mitochondrion-protecting drugs, selectively eliminates pathogenic autoantibodies by intravenous immunoglobulin (IVIg) and inhibits autoantibody production by cytotoxic immunosuppressors. Therefore, IVIg should be always added to the prednisone/rituximab regimen that does not eliminate circulating autoantibodies. To decrease risk for relapse to a minimum, PV should be maintained in full clinical remission until the critical mass of autoreactive plasma cells dies off. The two major factors that determine patient's risk for a relapse are the composition of the pool of pathogenic autoantibodies and the innate abilities of keratinocytes to sustain an autoantibody attack. As it is currently impossible to evaluate the risk for a relapse, development of a biomarker assay that could do so would be helpful in a long-term management of PV patients. We compared the magnitude of cytochrome c (CytC) release in keratinocytes by serum from PV patients in acute disease stage vs. remission and identified very strong positive correlation with disease severity. PV patients whose serum contained autoantibodies requiring higher amounts of normal IgG to neutralize their ability to release CytC were found to be at a higher risk for disease relapse. However, lack of very strong statistical correlation suggested that CytC is not an ideal biomarker to predict disease relapse, which should prompt a search for alternative candidates.

Safety of liquid intravenous immunoglobulin for neuroimmunologic disorders in the home setting: a retrospective analysis of 1085 infusions.

OBJECTIVE: To examine the overall safety of intravenous immunoglobulin (IVIG) administered according to a clinically defined, home-based therapeutic regimen in patients with neuroimmunologic diseases. METHODS: A total of 1,085 infusions of a new liquid IVIG 10% preparation were administered to 70 patients diagnosed with neuroimmunologic diseases over a 9-month period. These infusions were retrospectively reviewed for safety and tolerability. RESULTS: A very favorable adverse effect (AE) rate (4.7%) was calculated over a wide range of doses (0.9-2.14 g/kg). There were no serious AEs reported, even among patients naive to IVIG therapy. Of 51 nonserious AEs, 53% occurred in 5 patients. CONCLUSIONS: The results of this review of 1,085 high-dose liquid IVIG infusions using a closely monitored, yet highly flexible, home-based therapeutic regimen indicate a very favorable tolerability profile in patients with neuroimmunologic disorders, even in those who were new to IVIG therapy.