Table 2. Characteristics of Pregnant SLE Patients at Baseline and Their Association with Adverse Pregnancy Outcome.
| Patient Characteristic | Total N=385 (%) | No AP0 N=312 (%) | APO N=73 (%) | P-value* | |
|---|---|---|---|---|---|
|
| |||||
| Demographic | Site, N (%) | 0.033 | |||
| NYU | 95 (24.7) | 82 (26.3) | 13 (17.8) | ||
| Toronto | 95 (24.7) | 77 (24.7) | 18 (24.7) | ||
| Johns Hopkins | 86 (22.3) | 75 (24.0) | 11 (15.1) | ||
| Hospital for Special | 47 (12.2) | 33 (10.6) | 14 (19.2) | ||
| Surgery | 29 (7.5) | 23 (7.4) | 6 (8.2) | ||
| University of Utah | 22 (5.7) | 14 (4.5) | 8 (11.0) | ||
| Oklahoma | 8 (2.1) | 6 (1.9) | 2 (2.7) | ||
| University of Chicago | 2 (0.5) | 1 (0.3) | 1 (1.4) | ||
| Columbia | 1 (0.3) | 1 (0.3) | 0 (0.0) | ||
| Northwestern | |||||
|
| |||||
| Ethnicity/Race, N (%) | 0.053 | ||||
| Non-Hispanic White | 184 (47.8) | 157 (50.3) | 27 (37.0) | ||
| Hispanic White | 58 (15.1) | 43 (13.8) | 15 (20.6) | ||
| African American | 78 (20.3) | 58 (18.6) | 20 (27.4) | ||
| Asian | 42 (10.9) | 36 (11.5) | 6 (8.2) | ||
| Other | 10 (2.6) | 10 (3.2) | 0 (0.0) | ||
| Don't know/Refused to answer | 13 (3.4) | 8 (2.6) | 5 (6.9) | ||
|
| |||||
| BMI, N (%) | 0.048 | ||||
| <25 | 217 (60.3) | 183 (62.9) | 34 (49.3) | ||
| 25-30 | 82 (22.8) | 65 (22.3) | 17 (24.6) | ||
| >30 | 61 (16.9) | 43 (14.8) | 18 (26.1) | ||
| Missing | 25 | 21 | 4 | ||
|
| |||||
| Mean Age (SD), N=385 | 30.93(4.9) | 31.04 (4.8) | 30.49 (5.3) | 0.39 | |
|
| |||||
| Clinical History | Pregnancy Number, N (%) | 0.36 | |||
| 1 | 159 (41.3) | 135 (43.3) | 24 (32.9) | ||
| 2 | 102 (26.5) | 82 (26.3) | 20 (27.4) | ||
| 3 | 66 (17.1) | 51 (16.4) | 15 (20.6) | ||
| 4+ | 58 (15.1) | 44 (14.1) | 14 (19.2) | ||
|
| |||||
| Renal Disease, N (%) | 0.042 | ||||
| No | 265 (68.8) | 222 (71.2) | 43 (58.9) | ||
| Yes | 120 (31.2) | 90 (28.9) | 30 (41.1) | ||
|
| |||||
| Platelets <100,000, N (%) | 0.058 | ||||
| No | 319 (82.9) | 264 (84.6) | 55 (75.3) | ||
| Yes | 66 (17.1) | 48 (15.4) | 18 (24.7) | ||
|
| |||||
| Prior Thrombosis, N (%) | 0.014 | ||||
| No | 354 (92.0) | 292 (93.6) | 62 (84.9) | ||
| Yes | 31 (8.1) | 20 (6.4) | 11 (15.1) | ||
|
| |||||
| Prior Fetal Death > 10 | 0.002 | ||||
| weeks, N (%) | 344 (89.4) | 286 (91.7) | 58 (79.5) | ||
| No | 41 (10.7) | 26 (8.3) | 15 (20.6) | ||
| Yes | |||||
|
| |||||
| Prior Premature Birth <34 | 0.104 | ||||
| weeks, N (%) | 378 (98.2) | 308 (98.7) | 70 (95.9) | ||
| No | 7 (1.8) | 4 (1.3) | 3 (4.1) | ||
| Yes | |||||
|
| |||||
| Laboratory Values | Anti-dsDNA, N (%) | 0.51 | |||
| Negative | 219 (58.4) | 180 (59.2) | 39 (54.9) | ||
| Positive | 156 (41.6) | 124 (40.8) | 32 (45.1) | ||
| Missing | 10 | 8 | 2 | ||
|
| |||||
| aPL***, N (%) | <0.001 | ||||
| Negative | 337 (87.5) | 285 (91.4) | 52 (71.2) | ||
| Positive | 48 (12.5) | 27 (8.7) | 21 (28.8) | ||
|
| |||||
| LAC, N (%) | <0.001 | ||||
| Negative | 351 (91.2) | 297 (95.2) | 54 (74.0) | ||
| Positive | 34 (8.8) | 15 (4.8) | 19 (26.0) | ||
|
| |||||
| Anti-Ro, N (%) | 0.21 | ||||
| Negative | 221 (59.1) | 175 (57.6) | 46 (65.7) | ||
| Positive | 153 (40.9) | 129 (42.4) | 24 (34.3) | ||
| Missing | 11 | 8 | 3 | ||
|
| |||||
| Anti-La, N (%) | 0.57 | ||||
| Negative | 311 (84.3) | 253 (83.8) | 58 (86.6) | ||
| Positive | 58 (15.7) | 49 (16.2) | 9 (13.4) | ||
| Missing | 16 | 10 | 6 | ||
|
| |||||
| Protein > 500mg/day, N (%) | 0.40 | ||||
| No | 339 (91.1) | 277 (91.7) | 62 (88.6) | ||
| Yes | 33 (8.9) | 25 (8.3) | 8 (11.4) | ||
| Missing | 13 | 10 | 3 | ||
|
| |||||
| Platelets | |||||
| Mean (SD), N=379 | 253.04 (84.3) | 259.13 (85.8) | 226.17(71.6) | 0.003 | |
| < 100,000, N (%) | |||||
| No | 370 (97.6) | 304 (98.4) | 66 (94.3) | 0.065 | |
| Yes | 9 (2.4) | 5 (1.6) | 4 (5.7) | ||
| Missing | 6 | 3 | 3 | ||
|
| |||||
| Low Complement**, N (%) | 0.019 | ||||
| No | 252 (66.0) | 213 (68.7) | 39 (54.2) | ||
| Yes | 130 (34.0) | 97 (31.3) | 33 (45.8) | ||
| Missing | 3 | 2 | 1 | ||
|
| |||||
| Mean C3 in g/L (SD), N=364 | 1.05 (0.3) | 1.05 (0.3) | 1.02 (0.3) | 0.31 | |
|
| |||||
| Mean C4 in g/L (SD), N=358 | 0.20 (0.1) | 0.20 (0.1) | 0.19 (0.1) | 0.60 | |
|
| |||||
| Disease Activity | SLEPDAI | ||||
| Mean (SD), N=381 | 2.79 (3.0) | 2.58 (2.9) | 3.68 (3.2) | 0.005 | |
| > 4 | 0.009 | ||||
| No | 311 (81.6) | 260 (84.1) | 51 (70.8) | ||
| Yes | 70 (18.4) | 49 (15.9) | 21 (29.2) | ||
| Missing | 4 | 3 | 1 | ||
|
| |||||
| PGA | |||||
| Mean (SD), N=367 | 0.39 (0.5) | 0.35 (0.5) | 0.59 (0.6) | 0.005 | |
| > 1 | |||||
| No | 328 (89.4) | 275 (91.7) | 53 (79.1) | 0.003 | |
| Yes | 39 (10.6) | 25 (8.3) | 14 (20.9) | ||
| Missing | 18 | 12 | 6 | ||
|
| |||||
| Current Medications | Glucocorticoids, N (%) | 0.29 | |||
| No | 232 (60.3) | 192 (61.5) | 40 (54.8) | ||
| Yes | 153 (39.7) | 120 (38.5) | 33 (45.2) | ||
|
| |||||
| Hydroxychloroquine, N (%) | 0.38 | ||||
| No | 136 (34.3) | 107 (34.3) | 29 (39.7) | ||
| Yes | 249 (64.7) | 205 (65.7) | 44 (60.3) | ||
|
| |||||
| Azathioprine, N (%) | 0.184 | ||||
| No | 316 (82.1) | 260 (83.3) | 56 (76.7) | ||
| Yes | 69 (17.9) | 52 (16.7) | 17 (23.3) | ||
|
| |||||
| Heparin, N (%) | 0.009 | ||||
| No | 302 (78.4) | 253 (81.1) | 49 (67.1) | ||
| Yes | 83 (21.6) | 59 (18.9) | 24 (32.9) | ||
|
| |||||
| Aspirin, N (%) | 0.48 | ||||
| No | 250 (64.9) | 200 (64.1) | 50 (68.5) | ||
| Yes | 135 (35.1) | 112 (35.9) | 23 (31.5) | ||
|
| |||||
| Antihypertensives, N (%) | < 0.001 | ||||
| No | 352 (91.4) | 295 (94.6) | 57 (78.1) | ||
| Yes | 33 (8.6) | 17 (5.5) | 16 (21.9) | ||
APO = adverse pregnancy outcome; anti-dsDNA = anti-double stranded DNA; LAC = lupus anticoagulant; SLEPDAI = Systemic Lupus Erythematosus Pregnancy Disease Activity Index; PGA = physician's global assessment
*
P-values based on available data; proportion of missing data < 10% for all variables
**
Low is defined as C3 and/or C4 below normal value in the local laboratory
***
APL is defined as aCL IgG ≥40 GPL units; IgM ≥40 MPL units and/or positive LAC: RVVT, Kaolin, dilute TTI or PTT LA and/or anti-β2GPI IgG ≥40 GPL units; IgM ≥40 MPL units at least twice between 6 weeks and 5 years apart of which one must be during the PROMISSE pregnancy at a core lab, as previously described (21).