Table 4.
Numbers of specific types of damage events (rate per 10 person-years) in groups classified by prior Clinical Remission on Treatment experience.
| Damage Type | Percentage of Prior visits in Clinical Remission On Treatment | P-value for trend2 | ||||
|---|---|---|---|---|---|---|
| None (1374 PY1) | <25% (1681 PY1) | 25–50% (1195 PY1) | 50–75% (700 PY1) | 75%+ (232 PY1) | ||
| Arthritis (deforming or erosive) | 10 (0.08) | 8 (0.05) | 3 (0.03) | 2 (0.04) | 0 (0.00) | 0.050 |
| Avascular Necrosis | 25 (0.22) | 9 (0.06) | 3 (0.03) | 0 (0.00) | 1 (0.05) | <0.0001 |
| Cataract | 27 (0.25) | 24 (0.18) | 20 (0.20) | 7 (0.11) | 4 (0.18) | 0.091 |
| Cognitive Impairment | 5 (0.04) | 7 (0.05) | 5 (0.05) | 5 (0.08) | 0 (0.00) | 0.89 |
| Cardiomyopathy | 7 (0.05) | 3 (0.02) | 1 (0.01) | 4 (0.06) | 1 (0.04) | 0.86 |
| Cranial or Peripheral Neuropathy | 11 (0.09) | 11 (0.07) | 5 (0.05) | 3 (0.05) | 0 (0.00) | 0.027 |
| Cerebrovascular Accident | 11 (0.09) | 5 (0.03) | 2 (0.02) | 4 (0.06) | 2 (0.09) | 0.51 |
| Diabetes mellitus | 7 (0.06) | 6 (0.04) | 2 (0.02) | 1 (0.01) | 0 (0.00) | 0.052 |
| End Stage Renal Disease | 14 (0.11) | 2 (0.01) | 2 (0.02) | 1 (0.01) | 0 (0.00) | 0.013 |
| Glomerular Filtration Rate <50% | 8 (0.06) | 0 (0.00) | 0 (0.00) | 1 (0.01) | 0 (0.00) | 0.045 |
| Infarction or resection of bowel below duodenum | 12 (0.10) | 11 (0.08) | 4 (0.04) | 2 (0.03) | 2 (0.09) | 0.14 |
| Malignancy | 16 (0.13) | 10 (0.07) | 13 (0.12) | 6 (0.09) | 0 (0.00) | 0.39 |
| Myocardial Infarction | 9 (0.07) | 7 (0.04) | 3 (0.03) | 3 (0.03) | 0 (0.00) | 0.23 |
| Osteomyelitis | 6 (0.04) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (0.04) | 0.16 |
| Osteoporosis with fracture or vertebral collapse | 34 (0.28) | 31 (0.22) | 13 (0.12) | 11 (0.17) | 3 (0.13) | 0.048 |
| Pleural Fibrosis | 9 (0.04) | 6 (0.04) | 3 (0.03) | 1 (0.01) | 0 (0.00) | 0.069 |
| Premature gonadal failure | 6 (0.05) | 3 (0.02) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0.045 |
| Pulmonary Fibrosis | 13 (0.10) | 7 (0.05) | 14 (0.13) | 6 (0.09) | 1 (0.05) | 0.53 |
| Pulmonary Hypertension | 10 (0.08) | 12 (0.08) | 8 (0.07) | 1 (0.01) | 2 (0.09) | 0.36 |
| Retinal change or optic atrophy | 5 (0.04) | 4 (0.03) | 6 (0.05) | 0 (0.00) | 1 (0.05) | 0.61 |
| Ruptured Tendon | 4 (0.03) | 7 (0.04) | 4 (0.03) | 1 (0.02) | 0 (0.00) | 0.33 |
| Seizures requiring therapy for at least 6 months | 7 (0.05) | 1 (0.01) | 3 (0.03) | 0 (0.00) | 0 (0.00) | 0.078 |
| Valvular Disease | 6 (0.05) | 4 (0.02) | 4 (0.03) | 3 (0.04) | 0 (0.00) | 0.52 |
1
PY=Person-years. The actual number of PY used to calculate rates for each damage item varies somewhat because follow-up after damage of that type occurs is not included.
2
Based on a logistic regression model treating LLDAS percentage as a quantitative predictor.