Levofloxacin treatment in patients with rheumatoid arthritis receiving methotrexate.

BACKGROUND

Sulfasalazine and tetracyclines are effective against rheumatoid arthritis (RA). Levofloxacin, the bacteriologically active isomer of ofloxacin, is used in the treatment of infections caused by periodontopathic bacteria and facultative anaerobic bacteria. The aim of this study is to evaluate the clinical efficacy, safety, and tolerability of levofloxacin in patients with rheumatoid arthritis.

METHODS

In a 6-month, double-blind trial, we randomly assigned 76 patients with persistently active rheumatoid arthritis despite at least 6 months of methotrexate therapy at a stable dose of 15 to 25 mg per week to receive either levofloxacin (500 mg) or placebo orally once daily while continuing to receive methotrexate. The change from baseline to six months in the swollen-joint count and tender-joint count was the primary measure of efficacy. Secondary endpoints included pain, quality of life, duration of morning stiffness, erythrocyte sedimentation rate, C-reactive protein level, and physician's and patient's global assessments. The data were also analyzed to determine the number of patients meeting American College of Rheumatology criteria for 20, 50, and 70% improvement.

RESULTS

The levofloxacin plus methotrexate was associated with the greatest reduction in the number of swollen or tender joints (P < 0.001). The levofloxacin plus methotrexate group also had significant improvement in many of the secondary outcome measures (P < 0.001). Levofloxacin was well tolerated. There were no dose-limiting toxic effects.

CONCLUSION

In patients with active rheumatoid arthritis who received methotrexate, treatment with levofloxacin significantly improved the signs and symptoms of rheumatoid arthritis.