Table 1.
Treatment guidelines for the use of etanercept
| A. | Inclusion criteria | ||
| Patients with active rheumatoid arthritis still presenting the following despite the use of one or more MHLW recommendation-level-ADMARDsa (methotrexate, bucillamine, or sulfasalazine) at a normal dose for more than 3 months: | |||
| (1) | Tender joints ≥6 | ||
| (2) | Swollen joints ≥6 | ||
| (3) | ESR ≥28mm/h or CRP ≥2.0 mg/dl | ||
| Also, the patients must meet the following as having low risk for opportunistic infections: | |||
| (1) | WBC ≥4000/mm3 | ||
| (2) | Peripheral blood lymphocytes ≥1000/mm3 | ||
| (3) | Serum β-d-glucan: negative | ||
| B. | Usage | ||
| The dose of etanercept is 10–25 mg administered twice weekly as a subcutaneous injection. A patient can self-inject etanercept only after the ability to self-inject is carefully assessed and appropriate training is provided by a health professional. | |||
| C. | Contraindication | ||
| 1. | Ongoing infection | ||
| 2. | Past history of serious infections in the last 6 months | ||
| 3. | Abnormal shadows on chest radiographs suggestive of old pulmonary tuberculosis (TB) or tuberculosis pleuritis | ||
| 4. | History of extra pulmonary TB or Pneumocystis carinii pneumonia | ||
| 5. | Congestive heart failure | ||
| 6. | Malignancy or demyelinating disease | ||
| D. | Caution | ||
| 1. | From the point of view of screening for infection (especially TB and opportunistic infections) as well as prevention of side effects, etanercept is recommended for clinical use at medical institutes where: | ||
| (1) | Chest X-rays can be obtained on the same day, and the X-ray can be interpreted by a pulmonologist, TB specialist, or radiologist | ||
| (2) | Opportunistic infections can be treated | ||
| 2. | Comprehensive TB screening should be conducted including an in-depth patient history, chest radiographs (chest CT whenever possible) and a PPD skin test. In patients with suspected TB, based on medical history, abnormal shadows on chest radiographs suggestive of old pulmonary TB, or with a PPD skin test positive (as evidenced by redness of at least 20 mm in diameter or the presence of induration), the treatment with etanercept may be considered in addition to anti-tuberculosis drugs only if the potential benefits outweigh the potential risks. | ||
MHLW, Ministry of Health, Labor and Welfare; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; WBC, white blood cells; TB, tuberculosis; CT, computed tomography; PPD, purified protein derivative
a Cited in the Diagnostic Manual and Evidence-based Treatment Guidelines