<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Brandt, Jan</style></author><author><style face="normal" font="default" size="100%">Khariouzov, Andre</style></author><author><style face="normal" font="default" size="100%">Listing, Joachim</style></author><author><style face="normal" font="default" size="100%">Haibel, Hildrun</style></author><author><style face="normal" font="default" size="100%">Sörensen, Helmut</style></author><author><style face="normal" font="default" size="100%">Rudwaleit, Martin</style></author><author><style face="normal" font="default" size="100%">Sieper, Joachim</style></author><author><style face="normal" font="default" size="100%">Braun, Jurgen</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">Successful short term treatment of patients with severe undifferentiated spondyloarthritis with the anti-tumor necrosis factor-alpha fusion receptor protein etanercept.</style></title><secondary-title><style face="normal" font="default" size="100%">The Journal of Rheumatology</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2004</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2004-03-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">531-538</style></pages><volume><style face="normal" font="default" size="100%">31</style></volume><issue><style face="normal" font="default" size="100%">3</style></issue><abstract><style  face="normal" font="default" size="100%">OBJECTIVE: Anti-tumor necrosis factor-a (TNF-alpha) therapy has been successfully used in patients with active ankylosing spondylitis (AS) and other subtypes of spondyloarthritis (SpA). Treatment options for patients with severe forms of undifferentiated spondyloarthritis (uSpA), a rather frequent SpA subset, are limited. In this open study we examined the efficacy of the TNF-alpha receptor fusion protein etanercept in patients with uSpA. METHODS: Ten patients classified to have uSpA according to modified European Spondylarthropathy Study Group criteria in a severe and active stage of disease were included in the study and received etanercept in a dosage of 25 mg two times a week for 12 weeks, followed by an observation period of 12 weeks. The following outcome variables were used: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Functional Index (BASFI), pain on a numerical rating scale, disability by the Funktionsfragebogen Hannover (FFbH), a validated questionnaire to assess functional disability, and quality of life (Medical Outcome Study Short Form-36, SF-36). The primary outcome variable was defined as &gt;or= 50% improvement of the BASDAI. RESULTS: Treatment with etanercept resulted in a &gt;or= 50% regression of disease activity in 60% (95% CI 31-83%) of the patients. The mean BASDAI at baseline of 6.1 (range 3.7-9.2) dropped significantly to 3.5 at Week 12 (0.8-8.7; p = 0.01). Function, spinal pain, peripheral arthritis, enthesitis, quality of life, and acute phase reactants improved similarly. The FFbH improved from 62.8% to 69.7%. After cessation of anti-TNF therapy, 4 out of 8 patients relapsed after an average of 4.5 weeks (range 3-6). Two patients went into longstanding remission. No severe adverse events or major infections were observed. CONCLUSION: This study strongly suggests that treatment with etanercept has short term efficacy in patients with active and severe uSpA. Since it is known that 30-50% of uSpA patients develop AS over time, it will be important to study whether this can be prevented by anti-TNF-alpha therapy.</style></abstract></record></records></xml>