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| John Flynn, M.D.
Treatment Clinical Outcomes | ||
| Treatment | ||
Abstract 452: Clinical response to withdrawal of anti-TNF therapy in patients with ankylosing spondylitis after three years of continuous treatment with Infliximab Background: This is a follow-up observation of a group of patients who were originally treated with Infliximab and continued this therapy for three years' time. They subsequently had their therapy withdrawn and were followed to determine if their disease would relapse and the time period until that relapse was determined. Methods: Forty-three patients had their Infliximab therapy discontinued after receiving this for three years. They were then followed with visits every three weeks to see if their disease relapsed based on specific criteria. If those patients did relapse, they were then re-infused with Infliximab at 5.0 mg/kg. Results: After following these patients for 52 weeks, 41 of 42 patients (97.6%) developed relapse and required re-infusion. Ten patients (24%) showed a relapse within 12 weeks and 38 patients (90.5%) within 36 weeks. All 41 patients who required re-infusion responded well to re-initiation of this medication with improvement in their signs and symptoms. Conclusion: This study shows quite convincingly that patients who previously responded well to TNF therapy have an exceedingly high rate of recurrence once this therapy is discontinued. Editorial Comments: Thus, while these therapies are very effective at controlling disease, they do not achieve a cure such that the therapy can be discontinued. This is consistent with what is being seen in rheumatoid arthritis. An area of future research will be to try to determine if the dosages can be decreased to a lower level and still maintain disease control. | ||
Abstract 453: Clinical response to long-term therapy with Infliximab in patients with ankylosing spondylitis: Results after three years Background: This study reports the efficacy of Infliximab treatment in patients with ankylosing spondylitis after three years of therapy. Methods: This study follows 43 patients with ankylosing spondylitis who are treated with Infliximab for a total of three years to determine their outcome at this period. They then compared the improvement seen in these patients that was experienced at one year to their clinical state at three years. Results: Of these patients, nearly two-thirds were felt to have a significant disease response (BASDAI 50%) that lasted three years. When comparing the groups' outcomes at the end of the first year with the end of the third year, there continued to be significant improvement. In this small group of patients, there were no major side effects that occurred during the third year of therapy. Conclusion: This demonstrates that Infliximab therapy can be continued over three years and is efficacious over that time. There was no evidence of loss of response or development of new adverse effects in this time. Editorial Comments: This is reassuring information that patients that are brought under control with this therapy can be maintained. While it is important to be ever vigilant for side effects, it was reassuring that no new safety issues were seen after three years of therapy. | ||
Abstract 1134: X-ray progression of patients with ankylosing spondylitis after two years of Infliximab therapy Background: While it has been shown that TNF-inhibitor therapy has been effective in decreasing the symptoms and MRI findings in patients with ankylosing spondylitis, its effect on the plain radiographic changes has not yet been reported. Methods: In this study, 210 patients were from different cohorts were evaluated using plain x-rays of the lumbar and cervical spine. X-rays were obtained at baseline and then two years later. They were scored using established criteria. Results: Forty patients studied were a group that had been treated with Infliximab. This group had radiographic progressions scores 0.4. This was less than the comparison groups, one who had not received treatment (1.3 unit progression) and another group with early disease who had 0.9 unit progression. Conclusions: This study suggests that initiation of TNF therapy can slow down radiographic progression of patients with established spinal disease. Editorial Comments: This provides additional information to suggest what has been demonstrated in rheumatoid arthritis and to a degree in psoriatic arthritis; specifically that the x-ray changes that are classic for ankylosing spondylitis can be inhibited to some degree with TNF therapy. This is a very active area of research in clinical trials of ankylosing spondylitis. We should expect to see more results evaluating this outcome reported in the next two to three years. | ||
| Clinical Outcomes | ||
Abstract 1216: Men with ankylosing spondylitis have increased risk of myocardial infarction Background: The prevalence of coronary artery disease has been shown to be increased in SLE and rheumatoid arthritis beyond known risk factors. It is presumed that this is due to the underlying inflammatory state of these diseases. So too does inflammation occur in ankylosing spondylitis where we know that the aortic root and the aortic valve can become damaged by inflammation. This study is the first to look at the rate of myocardial infarction in patients with ankylosing spondylitis compared to those without. Methods: Patients in the United Kingdom who had been diagnosed with ankylosing spondylitis between 1990-2002 were identified. These patients were then matched based on age to patients without ankylosing spondylitis to determine the rates of myocardial infarction in both groups. Results: Over 5,000 male patients with ankylosing spondylitis were identified and compared to a group without ankylosing spondylitis. Those patients with ankylosing spondylitis had nearly a 1.5 times greater rate of myocardial infarctions. This increased risk could not be explained by any differences in known risk factors for coronary artery disease, such as hypertension, elevated lipids, obesity, or diabetes. Conclusion: This information indicates that ankylosing spondylitis should be added to the list of diseases that have an increased risk of myocardial infarction. Editorial Comments: Physicians caring for this group need to be mindful of this and aggressive in addressing other known risk factors for myocardial infarction in this patient population. | ||
Abstract 1642: The effect of ankylosing spondylitis on health-related quality of life Background: When looking at patients with chronic inflammatory disease, it is important to look at the quality of life. Using measures that have been developed to study this aspect, it has been learned that patients with many forms of arthritis have severely limited quality of life. Using this method, we can also compare the quality of life impact that is caused by different diseases besides arthritis. Methods: One-hundred-twenty-nine patients who were participating in the placebo group of a study were asked to complete a validated quality of life questionnaire (SF-36). This questionnaire looks at quality of life as it pertains to physical functioning, physical problems, body pain, emotional problems, social functioning, and vitality. The results of the patients who completed this survey were compared to a nationally representative sample of patients with multiple conditions. Results: The patients with ankylosing spondylitis had significantly lower health-related quality of life compared to patients without this condition. The magnitude of the difference was so great that it would be like comparing a 21-year-old male without any health conditions to a 70-year-old male. When comparing these to other chronic diseases, the loss of quality of life is equal to or greater than that seen in rheumatoid arthritis, congestive heart failure, or diabetes. Editorial Comment: This is a very useful tool in looking at how health disease impacts a person's life. It is clear from this study that a profound impact occurs in those suffering from ankylosing spondylitis. This tool is also used to determine the difference that our interventions can make in treating people with ankylosing spondylitis and other conditions. | ||
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Abstract 436: The burden of disease in patients with ankylosing spondylitis and pre-radiographic axial spondyloarthritis Background: This study looks at patients with early spondyloarthritis prior to developing x-ray changes to see how symptomatic these patients are. Methods: Two-hundred-sixty-six patients from Germany were identified as having very early disease based on classification criteria that require back stiffness. They then separated this group out between those that had x-ray changes within the sacroiliac joints and those who did not, to determine if there was any difference in disease burden between these groups. Results: One-hundred-ninety patients had radiographic evidence of ankylosing spondylitis while 76 patients had normal x-rays and were considered "pre-radiographic spondyloarthritis." The mean age was similar in both groups at roughly 35 years. There was no significant difference between the groups with regard to disease activity as determined by a number of outcome measures including BASDAI and pain at night. Patients with pre-radiographic spondyloarthritis had somewhat better function and mobility. Conclusion: Despite the absence of radiographic changes, patients with the inflammatory symptoms of ankylosing spondylitis can have significant disease burden as measured by these parameters. Editorial Comment: This finding underscores the importance of early diagnosis in patients with inflammatory back disease even prior to the development of x-ray changes. It also challenges us to make the diagnosis of early ankylosing spondylitis in these patients. It will be very interesting to see future results from this cohort of patients in Germany to determine the progression of people with symptoms who have not yet developed radiographic changes. | ||
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Abstract 440: Ankylosing spondylitis and the risk of fracture Debby Vosse, Piet Geusens, Desiree van der Heijde, Sjef van der Linden, Cyrus Cooper, Tjeerd-Pieter van Staa Background: It is known that patients with ankylosing spondylitis can develop osteopenia and osteoporosis. It is also appreciated that these patients are at increased risk of developing spinal fractures. The overall risk of fractures, however, has not been clearly studied. Methods: In this study conducted in the United Kingdom, records were reviewed in over 200,000 patients who had fractures and compared this to an age- and gender-matched group of patients who did not have fractures. The medical records were reviewed in these patients to determine if they have ankylosing spondylitis. The two groups were then compared. Results: The prevalence of ankylosing spondylitis was 0.18% in the fracture group and 0.15% in the control group. Based on comparisons of these two groups, patients with ankylosing spondylitis had an increased risk of vertebral fractures, but no greater risk of forearm or hip fractures. It also suggested that those patients with ankylosing spondylitis who take NSAIDs are at reduced risk of fracture. Conclusion: This provides further evidence of the increased risk of vertebral fractures in patients with ankylosing spondylitis. Editorial Comments: It is very important that patients and their physicians be aware of this increased risk. Fractures can occur in patients with spinal fusion with only minor trauma. The next question that will need to be addressed is whether this risk can be decreased with use of DMARDS or with osteoporosis medicines like bisphosphonates. | ||
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