Original Article

Levofloxacin Treatment in Patients with Rheumatoid Arthritis Receiving Methotrexate

Authors: Mesut Ogrendik, MD


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.

Key Points

* High levels of oral anaerobic bacterial antibodies have been found in the serum and synovial fluid of rheumatoid arthritis (RA) patients.

* Sulfasalazine, tetracyclines, ornidazole, and clindamycin are effective against RA. This study suggests that levofloxacin is effective in patients with RA.

* Oral anaerobic bacteria could be important in the etiopathogenesis of RA.

* Levofloxacin treatment in rheumatoid arthritis is very economical compared with TNF-alpha blockers.

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