Table 3.
Distribution of Biomarker Values and Adjusted Odds Ratios for Immune Reconstitution Inflammatory Syndrome (IRIS) Case Patients and Associated Control Patients
| Biomarker | IRIS case patients (N = 28) | IRIS control patients (N = 56) | Adjusteda ORb (95% CI) | P |
| Baseline (pre-ART) | ||||
| D-dimer, mg/L | 1.4 (0.6–2.1) | 0.7 (0.4–1.2) | 2.8 (1.1–7.3) | .03 |
| CRP, mg/L | 4.4 (1.8–11.7) | 1.8 (0.6–6.2) | 2.1 (1.0–4.4) | .06 |
| IL-6, pg/mL | 4.3 (2.9–7.5) | 2.7 (1.7–4.5) | 2.0 (0.9–4.5) | .08 |
| IL-8, pg/mL | 10.5 (5.2–15.3) | 6.5 (4.6–11.8) | 1.6 (0.8–3.0) | .19 |
| IL-10, pg/mL | 8.9 (5.7–16.2) | 5.8 (3.5–8.5) | 2.0 (1.1–3.7) | .03 |
| IFN-γ, pg/mL | 5.0 (2.0–8.7) | 2.7 (1.6–4.6) | 1.8 (0.7–4.9) | .24 |
| TNF-α, pg/mL | 21.9 (16.3–27.9) | 15.0 (11.9–19.5) | 3.7 (1.4–10.1) | .01 |
| HA, ng/mL | 79.2 (52.1–158) | 49.9 (49.9–77.5) | 3.4 (1.1–10.7) | .03 |
| CXCL10, mg/L | 0.6 (0.4–1.0) | 0.6 (0.4–0.9) | 2.8 (1.1–7.3) | .03 |
| sCD14, x106 pg/mL | 2.9 (2.5–3.2) | 2.3 (2.1–2.8) | 2.0 (0.9–4.1) | .08 |
| Month 1 | ||||
| D-dimer, mg/L | 1.4 (1.0–2.3) | 0.6 (0.4–1.2) | 6.5 (1.4–29.6) | .02 |
| CRP, mg/L | 39.6 (9.1–109) | 3.1 (1.2–8.5) | 12.1 (2.3–63.5) | .003 |
| IL-6, pg/mL | 7.8 (3.1–16.5) | 2.3 (1.2–4.0) | 11.5 (2.1–62.8) | .005 |
| IL-8, pg/mL | 10.4 (5.2–21.9) | 5.2 (4.0–10.6) | 4.1 (1.3–12.4) | .01 |
| IL-10, pg/mL | 7.9 (6.1–20.5) | 5.9 (3.1–10.0) | 0.9 (0.5–1.6) | .70 |
| IFN-γ, pg/mL | 4.5 (2.5–19.6) | 1.9 (1.0–5.0) | 8.6 (1.9–38.6) | .005 |
| TNF-α, pg/mL | 22.7 (16.9–37.9) | 14.0 (11.0–18.4) | 434 (2 to >1000) | .03 |
| HA, ng/mL | 49.9 (49.9–79.5) | 49.9 (49.9–49.9) | 1.7 (0.5–6.6) | .42 |
| CXCL10, mg/L | 0.5 (0.3–1.6) | 0.3 (0.2–0.5) | 4.0 (1.1–14.9) | .04 |
| sCD14, x106 pg/mL | 2.9 (2.4–3.2) | 2.4 (2.1–2.7) | 1.6 (0.9–2.5) | .09 |
NOTE. Data are median (IQR) unless otherwise specified. IRIS events included 21 unmasking events: MAC (n = 11), cytomegalovirus (n = 2), KS (n = 2), PCP (n = 1), varicella zoster (n = 2), histoplasmosis (n = 1), isosporiasis (n = 1), and death due to acute hepatitis of unknown etiology (n = 1). Possible paradoxical events (n = 7) included 2 people with recurrent PCP, 2 persons with clinical deterioration and history of MAC at entry (1 died), cytomegalovirus, cryptococcal meningitis, tuberculosis (patient died), and 1 person who died with new lymphadenitis with a history of both cryptococcosis and Mycobacterium avium complex before initiation of antiretroviral therapy (ART). CI, confidence interval; CRP, C-reactive protein; HA, hyaluronic acid; IFN-γ, interferon-γ; IL-6, interleukin 6; IL-8, interleukin 8; IL-10, interleukin 10; IQR, interquartile range; OR, odds ratio; TNF-α, tumor necrosis factor α.
The odds ratios take into account the matching factors and are further adjusted for a history of an AIDS event and human immunodeficiency virus RNA levels prior to ART initiation. The models for month 1 are also adjusted for the log-transformed baseline value of the biomarker and randomization group for the study.
For HA, the odds ratio is for those with detectable (≥50 ng/mL) values compared with those with undetectable values. For other biomarkers the odds ratios are per IQR after log transformation.