INTRODUCTION: This 28-week, phase IIIb study assessed safety and maintenance of response to certolizumab pegol (CZP) in a diverse population of @entity309 ( @entity309 ) @entity1 , stratified by prior anti- @entity2874 exposure, concomitant @entity1499 ( @entity6822 ) use and disease duration. The ability to predict achievement of @entity258 activity (LDA) at week 28 from improvements in Disease Activity Score 28 (DAS28), erythrocyte sedimentation rate (ESR), swollen joint count (SJC) and Clinical Disease Activity Index (CDAI) up to week 12 was assessed. METHODS: The 28-week study population included all @entity1 who completed the double-blind (DB) phase and entered the open-label (OL) phase, receiving 200 mg CZP every 2 weeks ( @entity15724 ) >= 16 weeks. In the 12-week DB period, @entity1 with active @entity309 and an inadequate response to >= 1 disease-modifying antirheumatic drug (DMARD) were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4 then 200 mg Q2W) or placebo ( @entity15724 ), stratified by prior anti- @entity2874 use, concomitant use of @entity6822 and disease duration (<2 years vs. >= 2 years). RESULTS: A total of 955 @entity1 entered the OL phase. At week 28, similar clinical improvements were seen in those receiving CZP throughout (CZP    >    CZP; n   =   771) and those receiving placebo during the DB phase  and switching to CZP in the OL phase (placebo    >    CZP; n   =   184) (ACR20 response rate   =   59.7 % vs. 53.3 %; ACR50/ACR70 response rates were also similar). Effect of CZP treatment was similar regardless of prior anti- @entity2874 use, disease duration and concomitant DMARDs, based on ACR20 response rates. The percentage of @entity1 achieving DAS28(ESR) LDA at week 28 was calculated for DAS28(ESR), SJC or CDAI responders at earlier time points. Reductions from baseline (  ) of DAS28(ESR) <1.2,   SJC <25 % or   CDAI <10 by week 12 were associated with <9 % chance of achieving LDA at week 28 regardless of prior anti- @entity2874 exposure. Adverse event rates were similar for placebo    >    CZP and CZP    >    CZP @entity1 , with no new safety signals identified. CONCLUSIONS: A diverse population of @entity309 @entity1 with varying disease duration showed rapid and sustained clinical improvements on CZP treatment, regardless of prior anti- @entity2874 or concomitant DMARD use. Failure to achieve improvements in DAS28(ESR), SJC or CDAI within the first 12 weeks of CZP therapy was associated with a low chance of achieving LDA at week 28. No new safety signals were observed. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00717236 , 15 July 2008.

Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse XXXX population.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity6822 :: ('D008727', 'Chemical') :: ['MTX'] @entity15724 :: ('p|SUB|Q|2|W', 'ProteinMutation') :: ['Q2W'] @entity2874 :: ('MESH:C536657', 'Disease') :: ['TNF'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate'] @entity258 :: ('MESH:D009800', 'Disease') :: ['low disease'] @entity309 :: ('MESH:D001172', 'Disease') :: ['rheumatoid arthritis', 'RA']
@entity309 :: (MESH:D001172,Disease) :: ['rheumatoid arthritis']
