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[Side effects and efficiency of 15 mg and 25 mg methotrexate per week in chronic polyarthritis]
A Schnabel1, E Reinhold-Keller, V Willmann
1Abteilung für Klinische Rheumatologie, Medizinische Universität Lübeck.
Abstract:
To examine the rate of side effects and the dose dependence of side effects 185 consecutive patients with active rheumatoid arthritis were randomized to receive 15 mg (group A) or 25 mg (group B) methotrexate (MTX) per week and studied prospectively over 12 months. Dose adjustments were performed according to tolerability and efficacy. With 168 patients eligible for evaluation the rate of withdrawal for any reason was 26% in group A and 27% in B. Withdrawal due to side effects occurred in 16% versus 18%, dose reduction due to side effects in 10% versus 9%. The higher dose was associated with a significantly higher rate of gastrointestinal side effects (28% vs. 17%, p < 0.05) and a tendency for more frequent elevations of transaminases. Other side effects were not dose dependent. A significantly higher rate of dose reduction due to improvement (35% versus 10%, p < 0.001), a more rapid decline of morning stiffness, and a higher number of patients reporting marked improvement are evidence in favour of higher therapeutic efficacy of the higher dose. In conclusion, an initial dose of 25 mg MTX/week is not associated with a higher rate of limiting side effects as compared with 15 mg/week. The efficacy of doses up to 25 mg/week should be examined in more detail.
Insights
Higher doses of methotrexate (MTX) for rheumatoid arthritis show increased efficacy without significantly more side effects. A 25 mg weekly dose is comparable to 15 mg, suggesting further study of higher MTX doses is warranted.
Area of Science:
- Rheumatology
- Pharmacology
- Clinical Medicine
Background:
- Rheumatoid arthritis (RA) is a chronic autoimmune disease requiring effective treatment.
- Methotrexate (MTX) is a cornerstone therapy for RA, but optimal dosing for efficacy and tolerability is debated.
Purpose of the Study:
- To compare the side effect rates and dose dependence of methotrexate in active rheumatoid arthritis patients.
- To evaluate the therapeutic efficacy of different weekly methotrexate doses over a 12-month period.
Main Methods:
- 185 RA patients were randomized to 15 mg (Group A) or 25 mg (Group B) of MTX weekly for 12 months.
- Dose adjustments were based on tolerability and efficacy.
- Patient outcomes, including withdrawal rates, side effects, and clinical improvement, were prospectively monitored.
Main Results:
- Withdrawal rates due to side effects were similar between groups (16% vs. 18%).
- The 25 mg MTX dose group showed significantly more gastrointestinal side effects (28% vs. 17%, p < 0.05) and a trend for elevated transaminases.
- Higher MTX dosage led to significantly greater dose reductions for improvement (35% vs. 10%, p < 0.001) and enhanced clinical efficacy.
Conclusions:
- An initial weekly dose of 25 mg methotrexate is not associated with a higher rate of limiting side effects compared to 15 mg.
- The higher dose of methotrexate demonstrated superior therapeutic efficacy in active rheumatoid arthritis patients.
- Further investigation into the efficacy of methotrexate doses up to 25 mg weekly is recommended.