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dc.creatorCherouvim, E. P.en
dc.creatorZintzaras, E.en
dc.creatorBoki, K. A.en
dc.creatorMoutsopoulos, H. M.en
dc.creatorManoussakis, M. N.en
dc.date.accessioned2015-11-23T10:24:37Z
dc.date.available2015-11-23T10:24:37Z
dc.date.issued2004
dc.identifier10.1097/01.rhu.0000135551.47780.ba
dc.identifier.issn10761608
dc.identifier.urihttp://hdl.handle.net/11615/26633
dc.description.abstractBackground: Infliximab at the dose of 5 mg/kg per infusion has been shown effective for the treatment of active spondyloarthropathies. It is not clear if the 5 mg/kg is required in most patients. Objective: To evaluate the long-term efficacy and safety of infliximab at the lower dose of 3 mg/kg in patients with active and refractory ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Methods: Thirty patients were enrolled in a 78-week, single-center, prospective, open-label pilot study, including 16 patients with severe and active AS and 14 patients with active and refractory PsA. Infliximab (3 mg/kg, in combination with a stable dose of methotrexate was administered intravenously at 0, 2 and 6 weeks, and q8 weeks thereafter (schedule-A) and the improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; for AS patients) and Patient Global Assessment of Disease Activity (PDA; for PsA patients) was monitored at baseline and at every visit (primary variables). Patients who did not respond sufficiently at 14 weeks, as well as patients who relapsed at any time during follow-up, received infliximab every 4 weeks (treatment schedule-B). Three different statistical approaches (per-protocol, last observation carried forward and by intention-to-treat) were applied. Results: Ten patients discontinued treatment for various reasons, including 3 (10.0%) because of allergic reactions. Twenty patients (66.7%, 9 with AS and 11 with PsA) had completed 78 weeks of treatment (schedule-A, 11 patients; schedule-B, 9 patients). Of these patients, 18 (90.0%) showed optimal response (improvement ≥50%), including 13 (65.0%) with improvement ≥70%. ASsessments in AS (ASAS) 50% was attained by 7/9 AS patients (77.8%). At 78 weeks of treatment, statistically significant improvement of indices of disease activity, function and quality of life was observed by all statistical approaches applied. Conclusions: Infliximab at 3 mg/kg every 8 weeks or, if needed, every 4 weeks appears to be an effective and rather safe treatment of patients with active and refractory AS and PsA after 78 weeks of treatment.en
dc.sourceJournal of Clinical Rheumatologyen
dc.source.urihttp://www.scopus.com/inward/record.url?eid=2-s2.0-4043066300&partnerID=40&md5=44e011cd3bf0a0774f0d6f5f3ee064e2
dc.subjectAnkylosing spondylitisen
dc.subjectInfliximaben
dc.subjectPsoriatic arthritisen
dc.subjectSpondyloarthropathyen
dc.subjectTreatmenten
dc.subjectmethotrexateen
dc.subjectabscessen
dc.subjectadulten
dc.subjectarthralgiaen
dc.subjectarticleen
dc.subjectchillen
dc.subjectclinical articleen
dc.subjectdisease activityen
dc.subjectdisease severityen
dc.subjectdrug efficacyen
dc.subjectdrug safetyen
dc.subjectfemaleen
dc.subjectfeveren
dc.subjectfollow upen
dc.subjectheadacheen
dc.subjectheart palpitationen
dc.subjecthumanen
dc.subjecthypoglycemiaen
dc.subjectmaleen
dc.subjectmyalgiaen
dc.subjectnauseaen
dc.subjectpatient complianceen
dc.subjectpharyngitisen
dc.subjectpilot studyen
dc.subjectpriority journalen
dc.subjectrashen
dc.subjectrisk assessmenten
dc.subjectside effecten
dc.subjectskin infectionen
dc.subjectsomnolenceen
dc.subjecttonsillitisen
dc.subjecttooth diseaseen
dc.subjectupper respiratory tract infectionen
dc.subjecturticariaen
dc.subjectvomitingen
dc.titleInfliximab therapy for patients with active and refractory spondyloarthropathies at the dose of 3 mg/kg: A 20-month open treatmenten
dc.typejournalArticleen


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