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Sodium meclofenamate (Meclomen) in the treatment of juvenile rheumatoid arthritis. A segment I study
Abstract:
Thirty-nine patients with JRA were treated with sodium meclofenamate (Meclomen) during a 4-wk open-labeled, non-controlled trial. Increasing doses started at 3 mg/kg/d qid, up to 7.5 mg/kg/d, not to exceed 300 mg/d. Seven patients dropped out due to adverse side effects, and 1 from inefficacy. Efficacy analysis showed statistically significant decreases in several disease indices, in particular the duration of morning stiffness. Twenty-one patients who completed the 4-wk study entered an extended open-labeled study. Nine patients completed at least 9 months of sodium meclofenamate therapy. At 9 months, these 19 showed mean decreases in all rheumatologic disease indices measured. The drug has recently been approved by the Food and Drug Administration for use in adults.
Insights
Sodium meclofenamate (Meclomen) effectively reduced morning stiffness and other rheumatologic disease indices in juvenile rheumatoid arthritis (JRA) patients. Long-term treatment showed sustained efficacy in a subset of patients.
Area of Science:
- Rheumatology
- Pharmacology
Background:
- Juvenile rheumatoid arthritis (JRA) is a chronic inflammatory condition requiring effective long-term management.
- Non-steroidal anti-inflammatory drugs (NSAIDs) are a cornerstone of JRA treatment, but optimal agents and dosages require ongoing investigation.
Purpose of the Study:
- To evaluate the efficacy and tolerability of sodium meclofenamate in patients with JRA.
- To assess the long-term effects of sodium meclofenamate in a subset of JRA patients.
Main Methods:
- An open-labeled, non-controlled trial involving 39 JRA patients treated with sodium meclofenamate.
- Dose escalation from 3 mg/kg/d up to 7.5 mg/kg/d (max 300 mg/d) over 4 weeks.
- An extended open-labeled study for patients completing the initial 4-week trial.
Main Results:
- Statistically significant reductions in several disease indices, notably morning stiffness duration.
- Seven patients discontinued due to adverse effects; one due to inefficacy.
- Nineteen patients completing 9 months of therapy demonstrated sustained mean decreases in rheumatologic disease indices.
Conclusions:
- Sodium meclofenamate demonstrates efficacy in managing JRA symptoms, including significant reduction in morning stiffness.
- Long-term administration of sodium meclofenamate appears to maintain therapeutic benefits in a proportion of JRA patients.
- The recent FDA approval for adult use suggests broader applicability of this NSAID.