"Ten recommendations for the use of MTX in daily clinical practice focussed on RA were developed, which are evidence-based and supported by a large panel of rheumatologists, enhancing their validity and practical use.
- For patients starting MTX therapy, work-up should include clinical evaluation of risk factors for MTX toxicity, including alcohol intake; patient education; levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, complete blood count (CBC), creatinine; and chest radiographic examination obtained within the previous year. Serology for HIV, hepatitis B and hepatitis C, blood fasting glucose levels, lipid profile, and pregnancy test should also be considered.
- Oral MTX should be initiated at 10 to 15 mg/week. Depending on clinical response and tolerability, the dose should be escalated by 5 mg every 2 to 4 weeks up to 20 to 30 mg/week. For patients with inadequate clinical response or intolerance, parenteral administration should be considered.
- Prescription of at least 5 mg/week of folic acid given with MTX treatment is strongly recommended.
- When MTX is started or the dose is increased, ALT levels with or without AST, creatinine, and CBC should be checked every 1 to 1.5 months until a stable dose is reached, and every 1 to 3 months thereafter. At each visit, clinical evaluation should determine adverse effects and risk factors.
- If there is a confirmed increase in ALT/AST levels at more than 3 times the upper limit of normal (ULN), MTX should be stopped. After normalization, MTX may be reinstituted at a lower dose. If the ALT/AST levels are persistently elevated up to 3 times the ULN, the MTX dose should be adjusted. If ALT/AST levels are persistently elevated more than 3 times the ULN after discontinuation of MTX, diagnostic procedures should be considered.
- MTX is appropriate for long-term use because of its acceptable safety profile.
- In DMARD-naive patients, the balance of efficacy or toxicity favors MTX monotherapy vs combination with other conventional DMARDs. When MTX monotherapy does not control the disease, MTX should be considered as the foundation for combination therapy.
- MTX is a steroid-sparing agent that is recommended in giant-cell arteritis and polymyalgia rheumatica. It may also be considered for treatment of patients with systemic lupus erythematosus or (juvenile) dermatomyositis.
- In patients with RA who are undergoing elective orthopaedic surgery, MTX can be safely continued in the perioperative period.
- For at least 3 months before planned pregnancy, MTX should not be used for both men and women. MTX should not be used during pregnancy or breast-feeding.
