Profile of patient-reported GI-ADRs associated with etanercept in the Dutch Biologic Monitor.
| GI-ADRs in the Dutch Biologic Monitor (36 ADRs) | |
|---|---|
| Burden scorea, mean ± SD | 2.6 ± 0.8 |
| No. of ADRs with contact HCPb | 24 (67) |
| Medical specialist | 15 (63) |
| General practitioner | 14 (58) |
| Nurse | 7 (29) |
| Pharmacist | 2 (8) |
| Other HCPc | 6 (25) |
| No. of ADRs with action by HCP | |
| Discontinuation | 1 (4) |
| Dose adjustment | 4 (17) |
| Treatment | 8 (33) |
| Referral to other HCP | 7 (30) |
| Mentioned, no action | 11 (46) |
| Other actiond | 3 (13) |
| No. of ADRs with own action | 23 (64) |
| No. of ADRs with outcome | |
| Recovered | 12 (33) |
| Improving | 8 (22) |
| Not recovered | 15 (42) |
| Aggravating | 1 (3) |
| No. of ADRs leading to hospitalizatione | 2 (6) |
| Naranjo Probability Scale | |
| Definite | 0 |
| Probable | 2 (6) |
| Possible | 34 (94) |
| Doubtful | 0 |
Values are expressed as n (%) unless otherwise indicated.
↵a 5-point Likert-type scale.
↵b Patients could report > 1 HCP.
↵c Contact with other HCPs include dental HCPs (dental hygienist or dentist): 5; nutritionist: 1.
↵d Other actions include examination: 2; adjusted moment of administration to the evening: 1.
↵e The 2 ADRs leading to hospitalization were described by 1 patient. ADR: adverse drug reaction; GI-ADR: gastrointestinal ADR; HCP: healthcare professional.