Objective. To investigate the effect of long-term antibiotic treatment in patients with reactive arthritis (ReA) and undifferentiated oligoarthritis. Methods. One hundred twenty-six patients were treated with ciprofloxacin (500 mg twice a day) or placebo for 3 months, in a double-blind, randomized study. Of these patients, 104 (48 treated with cipro-floxacin and 56 treated with placebo) were valid for clinical evaluation: 55 were diagnosed as having ReA with a preceding symptomatic urogenic or enteric infection and 49 as having undifferentiated oligoarthritis. These 2 groups were randomized separately. The triggering bacterium was sought by serology and/or culture. The percentage of patients in remission after 3 months of treatment was chosen as the primary efficacy parameter. Results. A triggering bacterium could be identified in 52 patients (50%): Chlamydia trachomatis in 13, Yersinia in 14, and Salmonella in 25. No patient was positive for Campylobacter jejuni or for Shigella. No difference in outcome was found between treatment with ciprofloxacin or placebo in the whole group or in subgroups of patients with ReA or undifferentiated oligoarthritis. No difference was seen in patients with a disease duration <3 months. Ciprofloxacin was not effective in Yersinia-or Salmonella-induced arthritis but seemed to be better than placebo in Chlamydia-induced arthritis. This difference was not significant, however, which might be due to the small sample size. Conclusion. Long-term treatment of ReA with ciprofloxacin is not effective; however, it might be useful in the subgroup of patients who have Chlamydia-induced arthritis. This has to be proven in a bigger study focusing on patients with Chlamydia-induced arthritis.
Conclusions-Chlamydiatrachomatis, yersinia, and salmonella can be identified as the causative pathogen in about 50% of patients with probable or possible ReA if the appropriate tests are used. (Ann Rheum Dis 2001;60:337-343) Reactive arthritis (ReA) is a well known complication of enteric infections caused by yersinia, salmonella, shigella, and campylobacter, or of urogenital tract infections caused by Chlamydia trachomatis.
Oral prednisolone 50 mg per day, but not low dose prednisolone, showed a short-term response that was significantly higher than placebo. The clinical significance and the duration of this effect warrant further study.
Axial spondyloarthritis, which includes ankylosing spondylitis and psoriatic spondyloarthritis, is an important subtype of the spondyloarthritides. Tumor necrosis factor (TNF) antagonists are effective therapies for this partially heterogeneous group of rheumatic diseases in terms of signs, symptoms, and functioning, but they do not seem to substantially inhibit radiographic progression, which is mainly new bone formation in ankylosing spondylitis. However, they clearly reduce inflammation, as shown by MRI. TNF blockers are also efficacious in the treatment of extraspinal features of spondyloarthritis. In addition, evidence indicates that anti-TNF therapy works well in early axial disease. Other biologics are currently being investigated, as alternatives are needed for patients who fail anti-TNF therapy.
Background To date no clinical trials are available showing efficacy of moderatly dosed prednisolone for the therapy of active ankylosing spondylitis (AS). Objectives To evaluate the efficacy and safety of moderately dosed prednisolone versus placebo over 2 weeks in patients with active AS despite NSAID treatment. Methods Of 39 patients enrolled, 36 finished the trial. Patients were randomized to one of 3 groups. Prednisolone was given double blind as 20 mg (n=13), 50 mg (n=12) or Placebo (PBO) (n=14) orally every day over 2 weeks. Mean age of the patients was 41 years (range 19-72), mean disease duration was 14 years (range 1-55), HLA-B27 was positive in 71% of patients. Clinical outcome assessments included disease activity (BASDAI), function (BASFI), metrology (BASMI), patient’s global assessment and pain (PG), peripheral joint assessment, Berlin enthesitis score, and C-reactive protein (CRP). Primary endpoint of this study was improvement of BASDAI 50 at Week 2. Results Mean change of BASDAI was significantly higher in the 50 mg group, p=0.026, when compared to PBO whereas this was not the case for the other groups: PBOversus 20 mg, p=n.s., 20 mg versus 50 mg, p=n.s. More patients reached a BASDAI 50 response in the 50 mg versus the PBO group when compared to the other groups, p=n.s. When looked for the 4 BASDAI 50 responders compared to the 8 non responders in the 50 mg group at screening they were significantly younger (35 vs 46 years), had a better spinal mobility (BASMI 2.5 vs. 4.8), higher CRP-values (59 mg/l vs 18 mg/l) lower BASDAI (5.8 vs. 6.6) and a lower BASFI levels (4.4 vs. 8.9). When looked for changes between screening and week 2 within the groups, in the 20 mg group significant improvements were found for BASDAI and pain and in the 50 mg group for BASDAI, BASDAI morning stiffness, BASFI, PG, pain and BASMI (table). Other results are listed in the table below. Placebo (n=14)20 mg (n=13)50 mg (n=12) ScreeningWeek2ScreeningWeek2ScreeningWeek2 BASDAI 50 (%)NA8NA27NA33 BASDAI 20 (%)NA23NA45NA75 Mean BASDAI5,54.96.65.4*6.33.9* Mean BASFI5.65.06.55.57.43.5* Mean PG6.96.57.85.97.44.4* Mean Pain7.76.57.96.1*7.64.4* Mean BASMI3.84.25.24.34.03.1* Mean BASDAI m6.85.87.15.87.03.6* Mean CRP30.722.718.28.5*32.010.9 Arthritis1.00.52.002.00 Enthesitis3.02.05.03.45.23.4 BASDAIm – mean of BASDAI questions 5 and 6 for morning stiffness, Arthritis – number of swollen joints in patients with arthritis at Screening, Enthesitis – number of enthesitic regions in patients with enthesitis at Screening. *P<0.05 when compared to Screening values. Conclusions Prednisolone 50 mg showed significantly higher response rates when compared to placebo or 20 mg prednisolone for different outcome parameters in patients with active ankylosing spondyitis. However, 20 mg of prednisolone per day did not show such an effect and the 50 mg high dosis of prednisolone does not seem to be acceptable for a longer treatment period. Disclosure of Interest H. Haibel Grant/Research support from: Merck Germany KgaA, Consultant for: Abbott G...
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