Evaluation of IVIG for Prevention of Infections Occurring On-study and Treatment of Infection of Solid Organ Recipients With Secondary Antibody Deficiency: A Phase 2 Randomized Clinical Trial.
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Sarmiento Elizabeth, Montanchez Judith, Ezzahouri Ikram, Cifrian Jose, Ortiz-Bautista Carlos, Laporta Rosalia, Bravo Carles, Salcedo Magdalena, Rodriguez-Ferrero Maria Luisa, Gonzalez-Costello Jose, Segovia Javier, de Pablos Alicia, Mora Victor, Ussetti Piedad, Lopez Sonia, Sabe Nuria, Gomez-Bueno Manuel, Sousa Iago, Navas Paula, Diez-Villanueva Pablo, Aguilar Myriam, Fernandez-Yunquera Ainhoa, Anaya Fernando, Muñoz Patricia, Valerio Maricela, Mur Ana, Alarcon Alba, Limay Kristofer, Lopez-Hoyos Marcos, Lopez Francisco, Vionnet Ana, Serrano Manuel, Carbone Javier
Аннотация
METHODS: A phase 2, randomized, multicenter, open-label study of solid organ recipients with severe infection and SAD defined as serum IgG <600 mg/dL. The study evaluated the efficacy of adding a fixed protocol of IVIG early after detection of SAD to standard of care (SOC) for the prevention of infection occurring on-study and the treatment of infections, versus SOC. We also assessed reconstitution of humoral immunity in a substudy. Forty-four transplant recipients were randomized in 6 transplant centers in Spain. The IVIG protocol comprised 2 doses of 15 g (interval 7-15 d) followed by 3 doses of 20 g (interval 15-30 d). The primary endpoint was infection occurring on-study defined as a new severe infection after randomization.
RESULTS: Forty-two patients were included in the intention-to-treat analysis (IVIG arm, n = 21 versus non-IVIG arm, n = 21). The rate of infection occurring on-study was lower in patients randomized to receive IVIG versus SOC (23.8% versus 66.7%, Fisher exact test, P = 0.012). The median number of infections occurring on-study was lower in the IVIG group. The median total number of new admissions considered to be related to an infection occurring on-study was significantly lower in IVIG-treated patients. A significant increase in specific anti-cytomegalovirus IgG, anti-varicella zoster IgG, anti-Clostridium difficile toxins A and B IgG, and anti-tetanus toxoid IgG and IgG1 was demonstrated in the IVIG arm.
CONCLUSIONS: In solid organ recipients with severe infection and SAD, IVIG may reduce infection occurring on-study occurrence versus SOC.