Table 3.
Risk Factors for the Development of Infective Adverse Events (n = 86)
| Patients without IAE (n = 96) n (%) | Patients with IAE (n = 67) n (%) | HR | 95% CI | P (Cox-Mantel test) | ||
|---|---|---|---|---|---|---|
| Female sex | 51 (53) | 49 (73) | 1.93 | 1.12 | 3.31 | .017 |
| Age > 40 years | 64 (67) | 38 (57) | 0.95 | 0.58 | 1.55 | .835 |
| Disease features | ||||||
| Disease duration > 10 years | 49 (51) | 32 (48) | 0.96 | 0.60 | 1.56 | .877 |
| EDSS > 5 | 59 (62) | 36 (54) | 0.72 | 0.36 | 1.38 | .304 |
| Presence of comorbidities | 63/93 (68) | 41/64 (64) | 1.18 | 0.71 | 1.96 | .529 |
| Diagnosis | ||||||
| RRMS | 36 (38) | 42 (63) | 1.83 | 1.11 | 3.01 | .018 |
| PPMS | 21 (22) | 3 (5) | 0.29 | 0.09 | 0.91 | .035 |
| SPMS | 34 (35) | 21 (31) | 0.85 | 0.51 | 1.42 | .535 |
| NMO | 4 (4) | 1 (2) | 0.53 | 0.07 | 3.87 | .528 |
| Prior DMT | ||||||
| More than two prior DMT | 36 (38) | 38 (57) | 1.67 | 1.03 | 2.70 | .039 |
| MAbs exposure | 30 (31) | 31 (46) | 1.30 | 0.80 | 2.12 | .285 |
| Less than 4 weeks wash out time | 34/80 (43) | 33/57 (58) | 1.13 | 0.66 | 1.92 | .656 |
| MAbs | ||||||
| Alemtuzumab-based regimen | 24 (25) | 43 (64) | 2.24 | 1.35 | 3.72 | .002 |
| Ocrelizumab-based regimen | 34 (35) | 4 (6) | 0.20 | 0.07 | 0.55 | .002 |
| Rituximab-based regimen | 38 (40) | 20 (30) | 0.93 | 0.55 | 1.58 | .792 |
| Immune status | ||||||
| BL lymphocytopenia (<800 cells/μl) | 14 (15) | 16 (24) | 1.13 | 0.64 | 1.98 | .677 |
| BL CD4+ T-cell count < 200 cells/μl | 9/88 (10) | 12/62 (19) | 1.25 | 0.66 | 2.35 | .491 |
| Iatrogenic immune impairmenta | 38 (40) | 41 (61) | 1.21 | 0.73 | 2.00 | .463 |
Abbreviations: BL, baseline; CI, confidence intervals; DMT, disease-modifying therapies; EDSS, Expanded Disability Status Scale; HR, hazard ratio; IAE, infective adverse events; MAbs, monoclonal antibodies; NMO, neuromyelitis optica; PPMS, primary progressive multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis.
aDefined as new onset of lymphocytopenia and/or hypogammaglobulinemia and/or neutropenia during treatment.