PTU-110 Elevated C reactive protein in anti-TNF-naïve patients is associated with higher remission rates: Abstract PTU-110 Table 1

Abstract

Introduction: The CHARM trial1 demonstrated that adalimumab (ADA) was effective for the maintenance of remission in patients with moderate to severe Crohn's disease (CD), and that remission rates are influenced by a patient's baseline C reactive protein (CRP) concentration and prior anti-TNF experience.1 Patients who were either anti-TNF-naive or had an elevated baseline CRP achieved higher rates of remission than the general study population. In this post hoc analysis we examined whether patients who were anti-TNF-naive and had an elevated CRP at baseline could achieve higher remission rates than those previously reported. Method(s): Data from CHARM, a 56-week, randomised, placebo-controlled trial of ADA maintenance therapy, were analysed. All patients received open-label ADA during a 4-week induction period, and were then randomised to ADA (40 mg weekly or every other week [eow]) or placebo for a 52-week double-blind period. In this analysis, clinical remission at week 56 was determined for randomised responders (patients who had a decrease in CDAI >=70 at week 4 compared with baseline) who were naive to prior anti-TNF treatment, by baseline CRP subgroups (high: >=10 mg/l, vs low: <10 mg/l), using non-responder imputation. Remission rates for patients treated with weekly or eow ADA were compared with rates for placebo-treated patients, using Fisher's exact test. Result(s): ADA treatment (weekly or eow) resulted in statistically significantly greater rates of clinical remission at week 56 compared with placebo treatment in each CRP subgroup of anti-TNF-naive patients (Abstract PTU-110 table 1). The percentage of patients in clinical remission was greater in the high CRP subgroup for both weekly and eow ADA treatment. (Table presented) Clinical remission at week 56 in anti-TNF-naive patients in CHARM Conclusion In the CHARM trial, anti-TNF-naive patients with baseline CRP>=10 mg/l experienced greater rates of clinical remission, regardless of ADA dose frequency, compared with patients with baseline CRP<10 mg/l.