Long‐term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7‐year results from the PRECiSE 3 study. Issue 8 (22nd August 2014)

• Record Type: Journal Article
• Authors: Sandborn, W. J.; Lee, S. D.; Randall, C.; Gutierrez, A.; Schwartz, D. A.; Ambarkhane, S.; Kayhan, C.; Pierre‐Louis, B.; Schreiber, S.; Lichtenstein, G. R.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 40:Issue 8(2014)
• Page Start: 903
• Page End: 916
• Publication Date: 2014-08-22
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12930
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12930-abs-0001"> <title>Summary</title> <sec id="apt12930-sec-0001" sec-type="section"> <title>Background</title> <p>The efficacy and safety of certolizumab pegol (CZP) in moderate‐to‐severe Crohn's disease were demonstrated in two 26‐week double‐blind studies (PRECiSE 1 & 2).</p> </sec> <sec id="apt12930-sec-0002" sec-type="section"> <title>Aim</title> <p>To report the safety and efficacy outcomes of long‐term, CZP therapy from PRECiSE 3, in which patients received treatment up to 7 years treatment.</p> </sec> <sec id="apt12930-sec-0003" sec-type="section"> <title>Methods</title> <p>Patients completing PRECiSE 1 or 2 were eligible to enter PRECiSE 3 in which they received CZP 400 mg, open‐label, every 4 weeks (without additional induction therapy) for up to 7 years, for up to 91 doses from study start. Safety (adverse events, including infections and malignancies) and efficacy (Harvey–Bradshaw Index, faecal calprotectin, C‐reactive protein) were prospectively monitored. Remission was analysed using observed cases, last observation carried forward imputation and nonresponder imputation.</p> </sec> <sec id="apt12930-sec-0004" sec-type="section"> <title>Results</title> <p>A total of 595 patients entered the study; 117 (20%) completed 7 years. Discontinuation rates were 29.2%, 13.6%, 16.1%, 7.9%, 5.0%, 4.5% and 3.9% (years 1–7 respectively). During 1920 patient‐years of exposure to CZP, no new safety signals were observed. Incidence rates (new cases/100 patient‐years) for serious infections and malignant neoplasms were 4.37 and 1.06 respectively. No lymphoproliferative malignancies were reported. Clinical remission rates were ≥68% at each year (observed cases); rates by last observation carried forward and nonresponder imputation were 58% and 45% at year 1, 56% and 26% at year 3 and 55% and 13% at year 7 respectively.</p> </sec> <sec id="apt12930-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Certolizumab pegol was well tolerated in the long‐term treatment of Crohn's disease, with sustained remission in some patients continuing in the study for up to 7 years. ClinicalTrials.gov identifier NCT00552058.</p> </sec> </abstract>