OBJECTIVE: To assess safety and efficacy of infliximab in patients with ankylosing spondylitis (AS) through 102 weeks. METHODS:Patients (n = 279) with active AS were randomized to either group 1 (n = 78; placebo through week 24 and then infliximab 5 mg/kg from weeks 24 through 96) or group 2 (n = 201; infliximab 5 mg/kg through week 96). The primary efficacy end point at week 24 (>or=20% improvement in the ASsessment in Ankylosing Spondylitis International Working Group criteria [ASAS20]) was assessed with an intent-to-treat analysis of observed data. RESULTS: More patients in group 2 than group 1 achieved the ASAS20 response at week 24 (61.2% versus 19.2%; P < 0.001). By week 102, groups 1 and 2 were similar with regard to ASAS20 response (72.1% versus 73.9%); ASAS40 responses at week 102 were 45.9% versus 59.4%. No new safety issues were discerned. CONCLUSION:Infliximab demonstrated sustained efficacy and safety over 2 years in this large cohort of patients with active AS.
RCT Entities:
OBJECTIVE: To assess safety and efficacy of infliximab in patients with ankylosing spondylitis (AS) through 102 weeks. METHODS:Patients (n = 279) with active AS were randomized to either group 1 (n = 78; placebo through week 24 and then infliximab 5 mg/kg from weeks 24 through 96) or group 2 (n = 201; infliximab 5 mg/kg through week 96). The primary efficacy end point at week 24 (>or=20% improvement in the ASsessment in Ankylosing Spondylitis International Working Group criteria [ASAS20]) was assessed with an intent-to-treat analysis of observed data. RESULTS: More patients in group 2 than group 1 achieved the ASAS20 response at week 24 (61.2% versus 19.2%; P < 0.001). By week 102, groups 1 and 2 were similar with regard to ASAS20 response (72.1% versus 73.9%); ASAS40 responses at week 102 were 45.9% versus 59.4%. No new safety issues were discerned. CONCLUSION:Infliximab demonstrated sustained efficacy and safety over 2 years in this large cohort of patients with active AS.
Authors: Won-Tae Chung; Jung-Yoon Choe; Won Cheoul Jang; Su Min Park; Young Chang Ahn; Il Kyu Yoon; Tae-Hwan Kim; Youn-Hyoung Nam; Sung-Hoon Park; Sung-Won Lee; Seong-Kyu Kim Journal: Rheumatol Int Date: 2010-03-28 Impact factor: 2.631
Authors: Yong-Gil Kim; Dong Hyun Sohn; Xiaoyan Zhao; Jeremy Sokolove; Tamsin M Lindstrom; Bin Yoo; Chang-Keun Lee; John D Reveille; Joel D Taurog; William H Robinson Journal: Arthritis Rheumatol Date: 2014-10 Impact factor: 10.995
Authors: Martina Karpitschka; Patrizia Godau-Kellner; Herbert Kellner; Annie Horng; Daniel Theisen; Christian Glaser; Bernhard Brandlhuber; Maximilian Reiser; Sabine Weckbach Journal: Eur Radiol Date: 2013-03-15 Impact factor: 5.315
Authors: Désirée M van der Heijde; Dennis A Revicki; Katherine L Gooch; Robert L Wong; Hartmut Kupper; Neesha Harnam; Chris Thompson; Joachim Sieper Journal: Arthritis Res Ther Date: 2009-08-17 Impact factor: 5.156