Table 2.
Baseline demographic and clinical characteristics of 72 participants with early Lyme disease by v1 cluster groupa.
| Whole Sample | Cluster 0 | Cluster 1 | Cluster 2 | Overall p-value | 0 vs. 1 p-value | 0 vs. 2 p-value | 1 vs. 2 p-value | |
|---|---|---|---|---|---|---|---|---|
| n = 72b | n = 40 | n = 19 | n = 13 | |||||
| Age (years) | 49.5 [33.0–60.0] (20.0–77.0) |
49.0 [31.5–57.5] (21.0–73.0) |
53.0 [31.0–64.0] (20.0–71.1) |
50.0 [42.0–61.0] (23.0–77.0) |
0.649 | 0.434 | 0.504 | 0.939 |
| Female gender | 31 (43.1%) | 16 (40.0%) | 8 (42.1%) | 7 (53.9%) | 0.678 | 0.878 | 0.382 | 0.513 |
| Erythema migrans size (cm2) | 82.0 [50.0–157.0] (16.0–900.0) |
99.5 [52.0–169.0] (16.0–375.0) |
84.0 [48.0–144.0] (32.0–900.0) |
60.0 [50.0–126.0] (24.0–182.0) |
0.505 | 0.646 | 0.248 | 0.569 |
| Disseminated erythema migrans | 22 (30.6%) | 12 (30.0%) | 5 (26.3%) | 5 (38.5%) | 0.760 | 0.770 | 0.734 | 0.699 |
| Duration of illness (days) | 6.0 [4.0–10.0] (1.0–60.0) |
6.0 [4.0–9.5] (1.0–60.0) |
5.0 [4.0–16.0] (3.0–42.0) |
6.0 [3.0–6.0] (3.0–13.0) |
0.535 | 0.727 | 0.322 | 0.359 |
| Antibiotic treatment initiated at V1c | 27 (37.5%) | 21 (52.5%) | 4 (21.1%) | 2 (15.4%) | 0.013 | 0.022 | 0.019 | 1.000 |
| Number of new onset, Lyme-related symptoms | 6.0 [3.0–10.0] (0.0–26.0) |
8.5 [4.0–14.0] (0.0–26.0) |
6.0 [1.0–8.0] 0.0–13.0) |
5.0 [3.0–6.0] (1.0–10.0) |
0.025 | 0.025 | 0.052 | 0.924 |
| Absolute lymphocytes <1.1 × 103/μL | 14 (19.4%) | 8 (20.0%) | 2 (10.5%) | 4 (30.8%) | 0.331 | 0.476 | 0.459 | 0.194 |
| Liver function abnormalityd | 22 (30.6%) | 15 (37.5%) | 6 (31.6%) | 1 (7.7%) | 0.127 | 0.657 | 0.079 | 0.195 |
| Two-tier antibody positive (acute) | 18 (25.0%) | 13 (32.5%) | 3 (15.8%) | 2 (15.4%) | 0.322 | 0.177 | 0.305 | 1.000 |
| Two-tier antibody positive | 31 (43.1%) | 22 (55.0%) | 5 (26.3%) | 4 (30.8%) | 0.071 | 0.039 | 0.129 | 1.000 |
| PCR/ESI-MSe results: | ||||||||
| Skin (+)/blood (+) | 19/69 (27.5%) | 12/39 (30.8%) | 5 (26.3%) | 2 (18.2%) | 0.925 | 0.936 | 0.690 | 0.892 |
| Skin (+)/blood (–) | 29/69 (42.0%) | 15/39 (38.5%) | 8 (42.1%) | 6 (54.6%) | ||||
| Skin (–)/blood (–) | 21/69 (30.4%) | 12/39 (30.8%) | 6 (31.6%) | 3 (27.3%) | ||||
Data from categorical variables are presented as count (%). Data from normally distributed variables are presented as mean ± standard deviation (range) and from continuous variables without normal distribution as median (25th percentile, 75th percentile) (range). Comparisons by cluster group were performed using Kruskall-Wallis tests for overall p-value and Wilcoxon rank sum test for individual pairwise comparisons for continuous variables, and chi-square test for categorical variables.
N = 73 participants were included in this study. However, one did not have a V1 blood draw and therefore V1 cluster status could not be determined and they were dropped from this analysis.
Participants were eligible if they had initiated appropriate antibiotic treatment for Lyme disease <72 h from their baseline study visit.
Elevated liver function test defined as any one of the following: aspartate aminotransferase above 35 U/L, alanine transaminase above 40 U/L, or alkaline phosphatase above 130 U/L for males and above 115 U/L for females.
PCR and electrospray ionization mass spectrometry (39). Three participants were missing PCR/ESI-MS results.