Table 3.
Protocol deviations
| COBRA (n=81) | COBRA-light (n=81) | |
|---|---|---|
| Protocolised treatment deviations | 8 | 11 |
| No full dose methotrexate due to elevated liverenzymes or gastrointestinal adverse events | 5 | 5 |
| Reduction prednisolone due to adverse events | 1* | 2† |
| Reduction sulfasalazine due to adverse events | 1 | |
| Switch to leflunomide due to methotrexate intolerance | 1 | |
| Intra-articular injection | 3 | |
| Intramuscular injection | 1 | |
| Minor violations | 13 | 4 |
| No increase to full methotrexate | 9 | 2 |
| Inappropriate increase methotrexate | 2 | |
| Inappropriate step in patient with methotrexate intolerance | 1 | |
| Lower dose sulfasalazine | 1 | |
| Inadequate prednisolone dose | 1‡ | |
| No DMARD temporarily | 1 | |
| Major violations | 6 | 2 |
| No medication for weeks | 2 | |
| Mesalazine instead of sulfasalazine | 1 | |
| Permanent stop of DMARD | 1 | |
| Prednisolone not tapered to 7.5 mg | 1§ | |
| Anti-TNF started at week 13 | 1 | |
| Inappropriate step in patient with methotrexate intolerance | 1 | 1 |
*Prednisolone dose 0 mg/day.
†Prednisolone dose 0 and 5 mg/day.
‡Prednisolone dose 10mg/day.
§Prednisolone dose 15 mg/day.
DMARD, disease-modifying antirheumatic drug; TNF, tumour necrosis factor.