Baseline C-reactive protein (CRP) and plasma anti-TNF concentration in patients with active Crohnʼs disease treated with certolizumab pegol

Elevated serum CRP (>10 mg/L) is a biomarker of inflammation and disease severity. Low baseline CRP concentrations (<10 mg/L) are associated with high placebo response rates (47%-60%) in randomized clinical trials in patients with active Crohn's disease.1,2 A greater treatment effect with the TNF antagonist certolizumab pegol has been reported in patients with higher baseline CRP concentrations.1 However, in 2 randomized clinical trials evaluating certolizumab pegol in Crohn's disease, the efficacy of certolizumab pegol did not correlate with the baseline CRP.2,3 This post hoc analysis further explored the relationship between baseline CRP and plasma concentration of certolizumab pegol in patients with active Crohn's disease. The PRECiSE 2 (NCT00152425)3 and WELCOME (NCT00308581)4 trials enrolled adult patients (N=668 and 539, respectively) with active Crohn's disease (Crohn's disease Activity Index [CDAI] 220-450). In both trials patients who responded at Week 6 to induction therapy with certolizumab pegol (400 mg administered subcutaneously at Weeks 0, 2, and 4) were randomized to continuous therapy with certolizumab pegol (400 mg every 4 weeks in PRECiSE 2; 400 mg every 2 or 4 weeks in WELCOME) or placebo through Week 24. The analysis population included patients who had a baseline CRP concentration and a blood certolizumab pegol concentration at Week 6 for both PRECiSE 2 (n=567) and WELCOME (n=484). Blood samples for plasma certolizumab pegol concentration were collected at Week 6, stratified by baseline CRP (≥10 mg/L and <10 mg/L), and analyzed by remission subgroup. Remission was defined as a Week 6 CDAI score of ≤150. 50% (282/567) and 49% (235/484) of patients in PRECiSE 2 and WELCOME had elevated baseline CRP (≥10 mg/L) (range 10.0-244.0 mg/L). In both studies, the geometric mean plasma certolizumab pegol (gmCZP) at Week 6 was lower among patients with baseline CRP ≥10 mg/L than among patients with baseline CRP <10 mg/L. This trend was observed in the overall population and in each remission subgroup. A trend toward lower plasma certolizumab pegol levels at Week 6 was observed in patients with high baseline CRP levels, suggesting that further studies would help clarify the relationship between certolizumab pegol and CRP.

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