PTU-110 Elevated C reactive protein in anti-TNF-naïve patients is associated with higher remission rates: Abstract PTU-110 Table 1
Authors: W J Sandborn, J-F Colombel, M M Castillo, Q Zhou, R B Thakkar
Journal: Gut (2012)

<h3>Introduction</h3> The CHARM trial<sup>1</sup> demonstrated that adalimumab (ADA) was effective for the maintenance of remission in patients with moderate to severe Crohn9s disease (CD), and that remission rates are influenced by a patient9s baseline C reactive protein (CRP) concentration and prior anti-TNF experience.<sup>1</sup> Patients who were either anti-TNF-naïve 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-naïve and had an elevated CRP at baseline could achieve higher remission rates than those previously reported. <h3>Methods</h3> 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 naïve to prior anti-TNF treatment, by baseline CRP subgroups (high: ≥10 mg/l, vs low: &lt;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 Fisher9s exact test. <h3>Results</h3> 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-naïve 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. <h3>Conclusion</h3> In the CHARM trial, anti-TNF-naïve patients with baseline CRP≥10 mg/l experienced greater rates of clinical remission, regardless of ADA dose frequency, compared with patients with baseline CRP&lt;10 mg/l. <h3>Competing interests</h3> W Sandborn Grant/Research Support from: Centocor Ortho Biotech, Abbott Laboratories, and UCB Pharma, Consultant for: Centocor Ortho Biotech, Abbott Laboratories, UCB Pharma, and Merck (previously Schering Plough), J-F Colombel Shareholder with: Intestinal Biotech Development, Grant/Research Support from: Astra-Zeneca, Danisco, Danone, Dysphar, Ferring, Giuliani, Lesaffre, Mapi Naxis, Ocerra Therapeutics, Roquette, Schering-Plough, and UCB, Consultant for: Abbott Laboratories, ActoGeniX NV, Albireo Pharma, Astra Zeneca, Bayer Schering Pharma, Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Centocor, Chemocentryx, Cosmo Technologies, Danone France, Elan, Genentech, Giuliani, Given Imaging, GlaxoSmithKline, Merck, Millennium, NeoVacs, Ocerra, Otsuka American, PDL Biopharma, Pfizer, Ribo Vacs Biotech, Schering-Plough, Shire, Synta, Teva and Petah Tikva, Therakos, UCB, and Wyeth, Speaker bureau with: Abbott Laboratories, Astra Zeneca, Centocor, Elan, Falk, Ferring, Given Imaging, Otsuka American, PDL, Schering-Plough, Shire and UCB, M Castillo Shareholder with: Abbott, Employee of: Abbott, Q Zhou Employee of: Abbott, R Thakkar Shareholder with: Abbott, Employee of: Abbott. <h3>Reference</h3> 1. <b>Colombel JF</b>. <i>Gastroenterology</i> 2007;<b>132</b>:52.