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Single-Blind Randomized Trial of Combination Antibiotic Therapy
in Rheumatoid Arthritis
LUKE L. GOMPELS, ANGELA SMITH, PETER J. CHARLES, WENDY ROGERS, JOANNE SOON-SHIONG, ADAM MITCHELL, CAROLINE DORÉ, PETER W. TAYLOR, and CHARLES G. MACKWORTH-YOUNG
ABSTRACT. Methods. Twenty-one patients with active RA despite second-line treatment were randomized to receive either combination antibiotic therapy (treatment group, n = 11) or no additional therapy (control group, n = 10). Antibiotic therapy was given for 12 months and comprised oral tetracycline 250 mg twice daily, 3 times per week, and intravenous clindamycin infused on 5 consecutive days (300, 300, 600, 600, and 900 mg) followed by weekly infusions of 900 mg for 3 weeks and then fortnightly infusions for the remainder of the 12 months. The primary outcome measure was the American College of Rheumatology 20% (ACR20) response at the end of the initial treatment period of 12 months. Results. Five patients in the treatment group (45%) achieved an ACR20 response at 1 year compared to none in the control group (p = 0.04). Eight patients in the treatment group and 1 in the control group had a greater than 20% improvement in tender joint count (p = 0.008). There were also significant differences between the groups in physician and patient global assessments. Nine patients in the treatment group completed the 6 months' followup; of these, 3 sustained the ACR20 response. Conclusion. Combined antibiotic therapy with intravenous clindamycin and oral tetracycline may be useful in the management of active RA. A double-blind, placebo-controlled trial of therapy is justified. (J Rheumatol 2006;33:224-7) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Kennedy Institute of Rheumatology; Charing Cross Hospital; and Other Disease Group Statistics, MRC Clinical Trials Unit, London, England. Supported by a grant from the Peacock Charitable Trust. Dr. Doré is funded by the Arthritis Research Campaign. L.L. Gompels, MRCP, Charing Cross Hospital; A. Smith, BSc, Kennedy Institute of Rheumatology; P.J. Charles, CSci FIBMS; W. Rogers, BSc; J. Soon-Shiong, MSc; A. Mitchell, FRCR, Charing Cross Hospital; C. Doré, BSc, Other Disease Group Statistics; P.W. Taylor, PhD, Charing Cross Hospital; C.G. Mackworth-Young, MD, Kennedy Institute of Rheumatology and Charing Cross Hospital. Address reprint requests to Dr. C.G. Mackworth-Young, Charing Cross Hospital, Fulham Palace Road, London, W6 8RF, England. E-mail: c.mackworth-young@imperial.ac.uk Accepted for publication October 19, 2005.
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