OBJECTIVE: To obtain results of the second year extension of an original 3 month randomised, placebo controlled trial (and the 1 year extension study) assessing the use of infliximab, a monoclonal antibody to tumour necrosis factor alpha, for the treatment of patients with ankylosing spondylitis (AS). METHODS: Of the 54 patients with AS who completed the first year of the study, 52 continued to receiveinfliximab 5 mg/kg every 6 weeks up to week 102. The primary end point was the proportion of patients achieving at least 50% improvement from baseline in the Bath AS Disease Activity Index (BASDAI) at week 102. Other assessments included patient and physician global assessments, quality of life as assessed by Short Form-36, Bath AS Functional Index, Bath AS Metrology Index, and C reactive protein (CRP). RESULTS: Improvement in signs and symptoms of AS seen during the first year of the study was sustained during the second year. Forty nine patients (71% of 69 enrolled patients and 49/52 (94%) patients who started year 2) completed the study up to week 102. Thirty (58%) patients achieved at least 50% improvement from baseline in the BASDAI score at week 102. Scores for other efficacy assessments were similar at weeks 54 and 102. Median CRP levels remained low at weeks 54 and 102 (3.9 and 4.3 mg/l, respectively). Side effects during the second year of the study were similar to those of the first year of treatment with infliximab. CONCLUSIONS:Patients with AS treated for 2 years withinfliximab 5 mg/kg exhibited a good and durable clinical response.
RCT Entities:
OBJECTIVE: To obtain results of the second year extension of an original 3 month randomised, placebo controlled trial (and the 1 year extension study) assessing the use of infliximab, a monoclonal antibody to tumour necrosis factor alpha, for the treatment of patients with ankylosing spondylitis (AS). METHODS: Of the 54 patients with AS who completed the first year of the study, 52 continued to receive infliximab 5 mg/kg every 6 weeks up to week 102. The primary end point was the proportion of patients achieving at least 50% improvement from baseline in the Bath AS Disease Activity Index (BASDAI) at week 102. Other assessments included patient and physician global assessments, quality of life as assessed by Short Form-36, Bath AS Functional Index, Bath AS Metrology Index, and C reactive protein (CRP). RESULTS: Improvement in signs and symptoms of AS seen during the first year of the study was sustained during the second year. Forty nine patients (71% of 69 enrolled patients and 49/52 (94%) patients who started year 2) completed the study up to week 102. Thirty (58%) patients achieved at least 50% improvement from baseline in the BASDAI score at week 102. Scores for other efficacy assessments were similar at weeks 54 and 102. Median CRP levels remained low at weeks 54 and 102 (3.9 and 4.3 mg/l, respectively). Side effects during the second year of the study were similar to those of the first year of treatment with infliximab. CONCLUSIONS:Patients with AS treated for 2 years with infliximab 5 mg/kg exhibited a good and durable clinical response.
Authors: D O Clegg; D J Reda; M H Weisman; W D Blackburn; J J Cush; G W Cannon; M L Mahowald; H R Schumacher; T Taylor; E Budiman-Mak; M R Cohen; F B Vasey; M E Luggen; E Mejias; S L Silverman; R Makkena; F P Alepa; J Buxbaum; C M Haakenson; R H Ward; B J Manaster; R J Anderson; J R Ward; W G Henderson Journal: Arthritis Rheum Date: 1996-12
Authors: J Braun; J Brandt; J Listing; A Zink; R Alten; W Golder; E Gromnica-Ihle; H Kellner; A Krause; M Schneider; H Sörensen; H Zeidler; W Thriene; J Sieper Journal: Lancet Date: 2002-04-06 Impact factor: 79.321
Authors: Filip Baert; Maja Noman; Severine Vermeire; Gert Van Assche; Geert D' Haens; An Carbonez; Paul Rutgeerts Journal: N Engl J Med Date: 2003-02-13 Impact factor: 91.245
Authors: J Braun; J Brandt; J Listing; A Zink; R Alten; G Burmester; W Golder; E Gromnica-Ihle; H Kellner; M Schneider; H Sörensen; H Zeidler; J Reddig; J Sieper Journal: Arthritis Rheum Date: 2003-08
Authors: J Braun; J Zochling; E Märker-Hermann; G Stucki; H Böhm; M Rudwaleit; H Zeidler; J Sieper Journal: Z Rheumatol Date: 2006-12 Impact factor: 1.372
Authors: J Zochling; D van der Heijde; R Burgos-Vargas; E Collantes; J C Davis; B Dijkmans; M Dougados; P Géher; R D Inman; M A Khan; T K Kvien; M Leirisalo-Repo; I Olivieri; K Pavelka; J Sieper; G Stucki; R D Sturrock; S van der Linden; D Wendling; H Böhm; B J van Royen; J Braun Journal: Ann Rheum Dis Date: 2005-08-26 Impact factor: 19.103
Authors: D E Furst; F C Breedveld; J R Kalden; J S Smolen; G R Burmester; P Emery; E C Keystone; M H Schiff; P L C M van Riel; M E Weinblatt; M H Weisman Journal: Ann Rheum Dis Date: 2006-11 Impact factor: 19.103
Authors: D E Furst; F C Breedveld; J R Kalden; J S Smolen; G R Burmester; J Sieper; P Emery; E C Keystone; M H Schiff; P Mease; P L C M van Riel; R Fleischmann; M H Weisman; M E Weinblatt Journal: Ann Rheum Dis Date: 2007-11 Impact factor: 19.103
Authors: Anna Rita Giardina; Angelo Ferrante; Francesco Ciccia; Rosalia Impastato; Maria Concetta Miceli; Alfonso Principato; Giovanni Triolo Journal: Rheumatol Int Date: 2009-10-23 Impact factor: 2.631