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    • br Patients and Methods In

    2018-10-23


    Patients and Methods In this retrospective cohort study we included 87 patients referred for analysis of recurrent RTI in the period 1992 until 2014. The clinical and immunological screening before starting ART comprised infection history and immune status investigation according to the immune status protocol of that time (the Dutch National Working Group for Immunodeficiencies (WID) and European Society for Immunodeficiencies (ESID) protocols) (Vossen and Zegers, 1988, de Vries et al., 2000, de Vries, 2006). Data were retrieved from patient records. For every patient, the history and laboratory results, including response to pneumococcal vaccination, at time of immunological screening were collected, as well as clinical and laboratory follow up data after that time. Data were collected up until July 2014, or until a patient was lost to follow up or died. Thus, there was no fixed length of the follow-up period. If patients gave written consent their home pharmacy was contacted with a request for providing the patient\'s MG132 use. Antibiotics use was only available for patients who started with ART after 2002. The local medical ethics committee approved of the study and allowed contacting the pharmacies of patients that had passed away. The study was conducted in accordance with the principles of the Declaration of Helsinki (2013 version).
    Results Eighty-seven patients were included in the study. Patient characteristics prior to ART are shown in Table 1. Fifty-five patients were female. The median age was 61years at start of ART. In the majority of the patients comorbid conditions were present. Thirty-six patients were diagnosed with chronic obstructive pulmonary disease (COPD). COPD patients were significantly more likely to smoke or have smoked (32/36 COPD patients versus 20/51 non-COPD patients; p=0.0001) to use corticosteroid maintenance therapy (11/36 COPD patients versus 6/51 non-COPD patients; p=0.02), and to have been admitted to the hospital in the previous year (23/36 COPD patients versus 18/51 non-COPD patients; p=0.001). HRCT-scan of the thorax showed bronchiectasis in 27 patients and pulmonary fibrosis in 3 patients. Infectious episodes prior to ART included sinusitis in 62 patients, bronchitis in 80 patients and pneumonia in 62 patients. Twenty-eight patients had undergone sinus surgery. Patients reported to have had infections for a median of 5years (interquartile range 2–18.5years) at time of immunological screening. The results of the immune status investigations are shown in Supplementary Table 1. The group of mild immunodeficiency consists of 37 patients with IgGSD (n=27) or SAD (n=10). The group of severe immunodeficiency consists of 44 patients with CVID (n=15) or IPH (n=28). The total group includes these two groups, as well as patients with MGUS (n=5), IgA deficiency (n=1) and no immunological defect (n=1). Seventeen patients were initially treated with IVIG and 70 patients with SCIG. In two patients with anti-IgA antibodies, pre-treatment with SCIG was given prior to starting IVIG. Twenty patients switched from SCIG to IVIG and one patient from IVIG to SCIG. Seventeen types of adverse effects were reported in 15 patients during IVIG. Adverse effects were reported in 23 patients during SCIG (Table 2). Adverse effects were mild except in one patient who developed a moderately severe systemic reaction after changing to another brand of IVIG. In 11 patients the therapy was stopped because of mild adverse reactions or because the therapy itself was perceived as too burdensome. The total study group comprised 543 patient-years including 383 patient-years under ART. The median follow-up time was 62months (interquartile range 34.5–98.5). Thirty-seven patients were treated with IVIG during a median time of 23months (interquartile range 6–63) and 71 patients with SCIG during a median of 11months (interquartile range 7–50). The follow up of 10 patients, who were referred for immunological evaluation and initiation of ART, took place in the referring hospital. In 35 patients therapy with SCIG was discontinued after 4–8months to evaluate the effect. In 19 of these patients it was necessary to restart ART after median of 12months (interquartile range 2.5–15) due to increasing infection frequency. Details on comorbidities during the follow up, as well as details on mortality and the causes of death are shown in Supplementary Table 2. Mortality was associated with male gender (p=0.005), higher age at start of ART (p=0.007), COPD Gold 4 (p=0.02), and development of malignancy during follow up (p=0.0008).