[The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study].

AIM

To evaluate the efficacy and tolerability of the anti-tumor necrosis factor-alpha infliximab in patients with active ankylosing spondylitis (AS) in a 54-week multicenter open-label study.

SUBJECTS AND METHODS

The study enrolled 42 patients with AS who continued to have an active phase of the disease despite that they had received standard therapy. All but one patient had signs of active spondylitis; peripheral arthritis was noted in 52%; enthesitis was seen in 79%. Infliximab was administered in a dose of 5 mg/kg as 2-hour intravenous infusions; the second and third infusions were injected 2 and 6 weeks after the first one; all further infusions were used at an interval of 6-8 weeks.

RESULTS

Thirty-three (78.6%) of the 42 patients completed the trial. There was a considerable, at least 50%, improvement in the ASAS criteria in 84.8% of the patients who completed the trial. A substantial therapeutic effect was observed in the majority of patients just a week after the first infusion of infliximab. There was a statistically improvement in all the analyzed clinical effectiveness indicators, including the Bath AS Disease Activity Index (BASDAI); pain became less in the vertebral column and joints (on an average from 49.6 to 12.4 mm on the 100-mm visual analog scale); the level of C-reactive protein and the number of swollen and tender entheses were decreased. The patients' functional capacity improved considerably (the Bath AS Functional index (BASFI) decreased on average from 59.7 to 16.3 scores). Nine (21.4%) patients were withdrawn from the study ahead of time: 7 and 2 patients because of adverse reactions (AR) and contact loss, respectively. The most common ARs were airway infections (13.6%), hepatic dysfunction (12.0%), and herpes simplex virus infections (10.4%). Four patients developed the severest ARs (pulmonary tuberculosis, generalized psoriasis-like dermatitis, pneumonia, and abscess of the epithelial coccygeal tract); the outcome of all complications was good.

CONCLUSION

The results of the study suggest that infliximab has a high, rapidly occurring and stably preserving efficiency in most patients with active AS. The frequency and spectrum of ARs corresponded to the available data on the tolerability of infliximab.