Certolizumab Pegol Plasma Concentrations and Endoscopic and Clinical Outcomes in Crohnʼs Disease: A Post Hoc Analysis of the MUSIC Trial: Presidential Poster

Abstract

Purpose: The MUSIC trial (NCT00297648) demonstrated that certolizumab pegol (CZP) treatment in patients (pts) with active Crohn's disease (CD) and severe endoscopic disease showed improvement in both endoscopic and clinical outcomes as early as Wk 10.1 This post hoc analysis of data from the MUSIC trial evaluates the associations between serum plasma CZP concentrations and endoscopic and clinical outcomes at Wk 10. Methods: Adult pts (N=89) with active CD for ≥3 months and significant endoscopic lesions (ulcerations in ≥2 intestinal segments with CD Endoscopic Index of Severity [CDEIS] score ≥8) received open-label subcutaneous CZP 400 mg at Wks 0, 2, and 4 (induction dose) and then every 4 wks until Wk 54. CZP plasma concentrations were collected at Wk 8 (trough level) and stratified by quartiles. Rates of endoscopic response (CDEIS decrease from baseline >5) and remission (CDEIS <6) and of clinical response (CD Activity Index [CDAI] decrease from baseline ≥100) and remission (CDAI score ≤150) were determined at Wk 10. Results: A total of 45 pts received CZP 400 mg induction at 0, 2, and 4 wks and had an available CZP trough measurement at Wk 8 and response/remission status at Wk 10. At Wk 10, there was a significant difference between the CZP concentration quartiles regarding CDEIS response and remission rates (p=0.0016 and p=0.0302, respectively) (Table). A similar trend at Wk 10 was observed in clinical efficacy with a significant difference between the CZP concentration quartiles regarding CDAI remission (p=0.0378), while CDAI response did not achieve statistical significance (p=0.2993).Table: Proportions of pts achieving endoscopic and clinical outcomes by CZP plasma concentration quartiles (Q)Conclusion: This post hoc analysis of the MUSIC study identifies an association between endoscopic response and remission and clinical remission and higher plasma concentrations of CZP following standard induction therapy. Further prospective evaluation of the correlation between CZP plasma concentration and both endoscopic and clinical outcomes is warranted.