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Double-blind, randomized, placebo-controlled study of three-month treatment with the combination of ofloxacin and roxithromycin in recent-onset reactive arthritis.

Author(s): Kuuliala A(1), Julkunen H, Paimela L, Peltomaa R, Kautiainen H, Repo H, Leirisalo-Repo M.

Affiliation(s): Author information: (1)Department of Bacteriology and Immunology, Haartman Institute, University of Helsinki, Helsinki, Finland, antti.kuuliala@gmail.com.

Publication date & source: 2013, Rheumatol Int. , 33(11):2723-9

In a randomized, double-blind, placebo-controlled trial, 56 patients with recent-onset ReA [enteroarthritis, n = 47 (84%); uroarthritis, n = 9 (16%)] were randomly assigned to receive 200 mg ofloxacin and 150 mg roxithromycin twice daily (Combi, n = 26) or placebo (n = 30) for 3 months. Patients were assessed at entry, at 2 weeks, and at 1, 2, 3, 4, 5, and 6 months. The primary outcome measure was recovery from arthritis at 6 months, and secondary outcome measures were swollen and tender joint counts, Ritchie index, serum CRP level, erythrocyte sedimentation rate, and joint pain on a visual analogue scale at 6 months. After 6 months, 20 patients [77% (95% CI 56-91)] in Combi and 20 patients [67% (95% CI 47-83)] in placebo group had recovered from arthritis (p = 0.55), and all clinical and laboratory variables showed improvement with no statistically significant difference between groups. Adverse events were reported by 62% of the patients in the Combi versus 40% in the placebo group. In conclusion, outcome of ReA was good in both treatment groups. Three-month treatment with the combination of ofloxacin and roxithromycin had no advantage over placebo in patients with recent-onset ReA.

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