Μελέτη φλεγμονωδών σπονδυλοαρθροπαθειών

Abstract

The aim of the present study was to describe patients with SpA and more specifically to describe patients with AS according to the modified New York criteria and patients with PsA according to the ESSG criteria in Northwestern Greece. Moreover, to determine the long term efficacy, safety and reasons for anti-TNFα discontinuation in PsA in an open-label observational period of 5 years, but also to investigate the efficacy, safety and drug discontinuation in patients with ankylosing spondylitis treated with infliximab, as well as the drug survival for a period of 6 years. Moreover, due to the fact that there is still insufficient evidence related to the risks associated with the use of anti-TNF-a agents in pregnancy, we identified men with AS who had fathered healthy newborns during their treatment. Lastly, we examined bone density and body composition in patients with AS in order to determine the influence of the disease on bone loss and total body and soft tissue composition; we also aimed to determine their relationships with disease activity parameters. In this study 400 patients from our rheumatologic clinic records were recruited; 146 of them had AS and 254 had PsA. In general, we recorded data in relation to age, sex, the age of onset of the disease, as well as the duration of symptoms. Moreover, we recorded data concerning the duration of the psoriatic lesions and, also, the possible relationship between skin and articular involvement. Several similarities with those reported in other studies, except for some specific differences: 1. AS in our study was almost 7.5 times more often in men than in women, while in other studies was 3 times more often in men. 2. Peripheral involvement was not so often in our study compared to other reports. 3. Peripheral involvement in AS patients was more often in men than in women. 4. Dactylitis and onycholysis were less frequent than other reports. 5. Patients with SP was the most frequent subgroup since it was recorded in higher proportions than other studies. In this study we investigated the long term efficacy, safety and reasons for anti-TNFα discontinuation. 65 patients with severe PsA and recalcitrant severe psoriasis were recruited into this open label observational study between January 2003 and December 2003. All patients fulfilled the European Spondyloarthropathy Study Group criteria (ESSG criteria) (25) and were refractory to at least 2 DMARDs. The primary endpoint with regard to efficacy in PsA was the proportion of patients who met the Psoriatic Arthritis Response Criteria (PsARC). A secondary endpoint was the improvement of Psoriatic Arthritis Severity Index (PASI). Patients in all anti-TNFα blockers experienced significant improvement with regard to the PsARC criteria. This improvement was sustained for at least the 5 years of the study. Furthermore, a significant reduction was noted in the DAS-28 score as well as in the levels of acute phase reactants CRP and ESR during the study. Patients in both anti-TNFα blockers experienced significant improvement with regard to the 50%, 70% and 90% improvement of PASI score. Summarizing the adverse events in all groups, none of the patients experienced an opportunistic infection (including tuberculosis) during the study. There was no lupus-like syndrome developed and there were no reports of cytopenic or neurologic events. At the end of treatment, the survival of infliximab was 56.7%, for etanercept 76% and for adalimumab 50%. To investigate the efficacy, safety and drug discontinuation in patients with ankylosing spondylitis treated with infliximab, as well as the drug survival, Forty patients with ankylosing spondylitis treated with infliximab were included in this prospective, open label study. All patients fulfilled the New York revised criteria for ankylosing spondylitis and they were recruited between January 2003 and July 2003. . Clinical improvement according to the Bath Ankylosing Spondylitis Disease Activity Index 50% and the Ankylosing Spondylitis Assessment Study Group 20%, 40% and ASAS 5/6 were recorded. A significant improvement in the Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Assessment Study Group scores was noted in the first year which sustained through the sixth year of treatment. More specifically, after the sixth year of treatment, Bath Ankylosing Spondylitis Disease Activity Index 50% was achieved by 65% of patients (26/40), Ankylosing Spondylitis Assessment Study Group 20% by 72.5% (29/40), Ankylosing Spondylitis Assessment Study Group 40% was reached by 70% (28/40) of patients and Ankylosing Spondylitis Assessment Study Group 5/6 was achieved by 50% of the patients. Sustained clinical response as measured by the BASDAI and the ASAS criteria was associated to the results obtained for the other clinical and laboratory parameters. At the end of the sixth year there was a statistically significant reduction from baseline in patient and physician global disease assessments and in the mean CRP, ESR, BASDAI score as well as in the hematocrit and hemoglobin values. As far as the drug safety is concerned, none of the reported adverse events was serious; on the contrary, all treatment-related adverse events were mild to moderate in severity. Lastly, after the first and the second year of treatment, the survival rate of infliximab reached 95%, after the third year it was 80%, while after the fourth year it was 72.5%, which was maintained throughout the fifth and sixth year of therapy. Moreover, due to the fact that there is still insufficient evidence related to the risks associated with the use of anti-TNF-a agents in pregnancy, we identified men with AS who had fathered healthy newborns during their treatment. We described 4 male patients with AS who had no fertility problems during infliximab therapy. These cases provide some evidence of reassurance for men treated with infliximab. However, further prospective studies are necessary to clarify the effects of the drug on male fertility and to guide clinicians in appropriate councelling and therapeutic...