Article Text
Abstract
Objective: To investigate efficacy, toxicity, and drug discontinuation in patients with ankylosing spondylitis (AS) treated with infliximab.
Methods: 35 patients with AS with mean (SD) age 42.5 (12.6) years and mean (SD) disease duration 14.5 (8.0) years were studied for 2 years. Patients entering the study had a negative tuberculin skin test, were fully informed about the treatment, and were followed up regularly. Infliximab, 5 mg/kg weight, was given intravenously at weeks 0, 2, 6, and every 8 weeks thereafter. Data concerning infliximab tolerability, adverse events, interval, and drug discontinuation were all recorded. Clinical improvement according to the BASDAI and the Ankylosing Spondylitis Assessment Study group (ASAS) 20%, 40%, and ASAS 5/6 response criteria were recorded.
Results: After 1 year, 20 (57%) patients achieved the BASDAI 50% response criteria, 25 (71%) achieved ASAS 20%, 23 (66%) reached ASAS 40%, and 18 (51%) attained ASAS 5/6. After 2 years’ treatment, 11 (31%) patients achieved BASDAI 50% response criteria, 14 (40%) ASAS 20%, 11 (31%) ASAS 40%, and 9 (26%) ASAS 5/6. Clinical improvement was associated with an improved BASFI and reduction of CRP. After 2 years’ treatment, “infliximab survival” was 89%. Treatment was well tolerated and adverse events were mild; 3 patients discontinued the study.
Conclusion: Infliximab was effective, safe, and well tolerated in patients with AS.
- AS, ankylosing spondylitis
- ASAS, Ankylosing Spondylitis Assessment Study Group
- BASDAI, Bath Ankylosing Spondylitis Disease Activity Index
- BASFI, Bath Ankylosing Spondylitis Functional Index
- CRP, C reactive protein
- HACA, human antichimeric antibodies
- NSAIDs, non-steroidal anti-inflammatory drugs
- RA, rheumatoid arthritis
- VAS, visual analogue scale
- ASAS
- ankylosing spondylitis
- BASDAI
- compliance
- infliximab
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- AS, ankylosing spondylitis
- ASAS, Ankylosing Spondylitis Assessment Study Group
- BASDAI, Bath Ankylosing Spondylitis Disease Activity Index
- BASFI, Bath Ankylosing Spondylitis Functional Index
- CRP, C reactive protein
- HACA, human antichimeric antibodies
- NSAIDs, non-steroidal anti-inflammatory drugs
- RA, rheumatoid arthritis
- VAS, visual analogue scale