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    • The outcome measures of efficacy of antibody replacement the

    2018-10-23

    The outcome measures of efficacy of antibody replacement therapy are summarized in Table 3 and Fig. 1. Anamnestically patients had a median number of 5.50 infections per year (interquartile range 4.00–8.00; available in 50 patients). In the year prior to ART the median number of antibiotic courses was 4.00 (interquartile range 2.00–6.25; available in 46 patients). The mean number of hospital admissions was 0.75. Thirty of 76 patients were admitted at least one time in the year prior to ART. The yearly frequency of physician confirmed infections under ART was significantly lower than the anamnestically obtained infection frequency prior to therapy (p<0.001). The yearly frequency of nmda receptor antagonist use was significantly lower under ART compared to the year prior to ART (p<0.001). The antibiotics use decreased under ART in 33 out of 46 patients and increased in 10 patients. Clinical and outcome parameters were not significantly different between the two groups. There were no significant differences in age, gender, time to diagnosis, type of PAD, or comorbid conditions. The yearly number of hospital admissions was significantly lower under ART in the whole cohort compared to the year prior to ART (p=0.009). The number of hospital admissions decreased in 26 out of 76 patients, increased in 19 patients and 31 patients had no admissions before or under ART. In the group with an increase in hospital admissions 15 out of 19 patients were not admitted to the hospital in the year before ART. In these 19 patients, there were more current smokers (p=0.08) and significantly less ex-smokers (p=0.02). Nine patients showed radiologically confirmed emphysema on thorax HRCT (p=0.01 compared to patients with no increase in hospital admissions). Six of these 9 patients were current smokers. The combination of HRCT-confirmed emphysema and being a current smoker at the start of ART was significantly more present in patients with increased hospital admissions under ART (6/14 patients versus 2/57 patients; p=0.0005). Five of 19 patients had a malignancy before ART (p=0.02 compared to patients with no increase in hospital admissions). All 5 patients were considered disease free at the start of ART. There were no significant differences in age, gender, and time to diagnosis between the patients with an increase in hospital admissions compared to those with no increase in hospital admissions. Subgroup analysis, with CVID and IPH patients combined in one group (n=44) and SAD and IgGSD patients combined in another group (n=37) showed a significant decrease under ART of infection frequency (p<0.001 in both groups) and antibiotics use (p=0.002 in CVID/IPH and p=0.02 in SAD/IgGSD). The number of hospital admissions decreased in both groups as well, but not significantly in the severe immunodeficiency group (p=0.17 in CVID/IPH and p=0.03 in SAD/IgGSD). Before the start of ART, there were no significant differences in infection frequency, antibiotics use and number of hospital admissions. Outcome measures for the different administration routes are shown in Supplementary Table 3. All three outcome parameters decreased under both IVIG and SCIG, but not always significantly. Immunoglobulin levels at baseline and mean immunoglobulin levels under IVIG and SCIG are shown in Table 4. IgG levels increased significantly under antibody replacement therapy (p=0.001 for IVIG and p<0.001 for SCIG respectively). There were 27 patients with bronchiectasis. No significant correlation was found between bronchiectasis and the time since start of respiratory tract infections and start ART. Numbers of infections and hospital admissions prior to ART were not significantly different between patients with and without bronchiectasis. IgG and IgG1 levels prior to ART were significantly higher in the group of bronchiectasis patients (p=0.04 and p=0.02).
    Discussion The number of hospital admissions increased under ART in 19 patients. This was significantly associated with smoking status and radiologically confirmed emphysema and even more strongly with both factors combined. Smoking and chronic respiratory diseases are both known risk factors for severe RTI (Torres et al., 2013). Obviously, ART will not overcome structural lung damage. This raises the question whether there is an indication for ART in patients with progressive underlying respiratory disease and immunodeficiency. Nevertheless, it is not known whether the number of hospital admissions would have been even higher without ART. ART might slow disease progression, as infectious episodes can cause worsening of underlying respiratory disease. Despite existing comorbidity, most patients in our study showed a significant response to ART.