AZITHROMYCIN (AZ) IN REACTIVE ARTHRITIS (REA): A EULAR DOUBLE-BLIND STUDY COMPARING SHORT VERSUS LONG-TERM ANTIBIOTICS

T.K. Kvien , P.A. Plan , M. Altwegg , T. Bardin , I. Butrimiene , B.A. Dijkmans , J.S.H. Gaston , M. Leirisalo-Repo , T. Vischer Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, , Zurich, Switzerland, , Paris, France, , Vilnius, Lithuania, , Amsterdam, Netherlands, , Cambridge, United Kingdom, , Helsinki, Finland, , Geneva, SwitzerlandObjectives: Previous studies with small numbers of patients have not clarified whether the course of ReA is influenced by duration of antibiotic treatment. This Eular study was designed to compare the efficacy of 13 versus single week treatment with azithromycin (Az) in ReA.Methods: Patients were aged 16-55 years and were eligible for the trial if they had a swollen joint count (SJC) < 6, a disease duration < 2 months and the investigator considered ReA as a reasonable possibility. List of exclusions comprised several clinical and laboratory signs of chronic rheumatic disease, unstable medication with corticosteroids and NSAID, and use of antibiotics for more than 10 days in the last 30 days before study entry. All patients received 1 g Az at baseline and were then randomised to placebo (Pl) or Az weekly for 12 additional weeks. Assessments for efficacy and safety were performed every 4 weeks and separate analyses were performed for intention to treat (ITT) and for per protocol completers.Results: 155 (Az 81, Pl 74) patients, recruited from 12 different European countries (mean (SD) age 34.0 (9.5) yrs, 67.7% males, 53.7% HLA B27, disease duration 30.5 (17.4) days, SJC 2.4 (1.4), 20.6% with previous similar episode), were eligible for analyses (31 patients were excluded not fulfilling the entry criteria). Percentages completing per protocol were 70.4 in Az, 65.8 in Pl, withdrawals due to lack of efficacy/adverse events were 24.0/8.0 and 21.7/13.0%, respectively. 24-week changes in joint counts, reported joint pain, global scores and CRP were similar (ITT and completers). Disease course examined by repeated measurement ANOVA was also similar in the two groups. Results from Kaplan Maier survival analyses (ITT) are shown in the table (median (CI) weeks, log rank test). Adverse events were generally mild, but were more frequently reported in the Az group. Az (n=81) Pl (n=74) p-value Weeks to resolution of arthritis 16 (12.8, 19.2) 12 (4.6, 19.4) 0.83 Weeks to physician global=0 24 24 0.92 Weeks to patient global=0 24 24 0.99 Conclusion: This study does not support the hypothesis that long-term antibiotic therapy is more effective than short-term in patients with recent onset oligoarthritis where ReA is a reasonable diagnostic possibility.Citation: , volume , supplement , year 2002, page Session: Spondylarthropathies including psoriatic arthritis 2