Table 1.
Baseline characteristics of IVIG cohort with comparison to the Relaxin, D-Pen, Collagen and MMF studies.
| Variable | IVIG (n=30) |
Relaxin (n=231) |
D-Pen (n=134) |
Collagen (n=168) |
MMF (n=87) |
|---|---|---|---|---|---|
| Age at drug initiation, years, mean (SD) | 46.6 (12.3) | 47.3 (10.3) | 43.7 (12.4) | 50.8 (12.2) | 49.6 (11.2) |
| Duration from 1st non-Raynaud’s scleroderma symptom to drug initiation, months, mean (SD) | 24.6 (19.9) | 26.4 (16.4) | 9.5 (4.1)* | 41.8 (31.9)* | 24.4 (30.5) |
| Female gender, % | 80.0 | 85.2 | 77.6 | 79.2 | 83.9 |
| Race, % | |||||
| White | 86.7 | 74.0 | 67.9* | 76.2 | 78.0 |
| Black | 3.3 | 13.3 | 19.4* | 16.1 | 17.1 |
| Other | 10.0 | 12.8 | 12.7 | 7.7 | 4.9 |
| Modified Rodnan skin score, mean (SD) | 29.6 (7.2) | 27.3 (6.9) | 21.0* (8.0) | 26.1* (7.8) | 24.5 (9.5)* |
| Health Assessment Questionnaire DisabilityIndex, mean (SD), N=28 | 1.29 (0.70) | 1.09 (0.65) | |||
| Concomitant myositis, no. (%) | 5 (16.7) | 2 (2.3)* | |||
| Tendon friction rubs, no. (%) | 10 (33.3) | ||||
| Baseline CPK, mean (SD), N=18 | 265.8 (440.6) | ||||
| Renal crisis, no. (%) | 0 (0) | ||||
| Pulmonary function (% predicted), mean (SD) | |||||
| Forced vital capacity (FVC), N=29 | 83.1 (19.2) | ||||
| Diffusing capacity (DLCO), N=28 | 76.8 (20.2) | ||||
| Right ventricular systolic pressure (mmHg), mean (SD), N=19 | 32.1 (6.5) | ||||
| Medications used prior to IVIG initiation, no. (%) | |||||
| Prednisone | 19 (63.3) | ||||
| Methotrexate | 8 (26.7) | ||||
| Azathioprine | 3 (10.0) | ||||
| Cyclophosphamide | 8 (26.7) | ||||
| D-penicillamine | 3 (10.0) | ||||
| Hydroxychloroquine | 8 (26.7) | ||||
| Minocycline | 1 (3.3) | ||||
| Colchicine | 1 (3.3) | ||||
| TNF-inhibitor | 2 (6.7) | ||||
| Mycophenolate mofetil | 25 (83.3) | ||||
| Leflunomide | 1 (3.3) | ||||
| Imatinib | 2 (6.67) | ||||
| Rapamycin | 1 (3.3) | ||||
| Other** | 4 (13.3) | ||||
| Autoantibody status, no. (%) | |||||
| Anti-nuclear antibody (ANA) | 29 (96.7) | ||||
| Anti-centromere | 0 (0) | ||||
| Anti-topoisomerase 1 (Scl70) | 5 (16.7) | ||||
| Anti-RNA polymerase III, N=23 | 14 (60.9) | ||||
| Anti-ribonucleoprotein (RNP), N=29 | 2 (6.9) |
*
p<0.05 for comparison with IVIG cohort
**
One patient was treated with gold for RA, one patient was treated with alefacept in a clinical trial, and two patients were treated with chemotherapeutic agents (cetuximab and docetaxel, respectively).