Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation

7-Year Data from the PRECiSE 4 Study

Scott D. Lee, David T. Rubin, William J. Sandborn, Charles Randall, Ziad Younes, Stefan Schreiber, David A. Schwartz, Robert Burakoff, David Binion, Themos Dassopoulos, Razvan Arsenescu, Alexandra Gutierrez, Ellen Scherl, Cem Kayhan, Iram Hasan, Gordana Kosutic, Marshall Spearman, David Sen, Jason Coarse, Stephen Hanauer

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. Methods: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks. We assessed safety (adverse events) and efficacy (clinical remission) of extended certolizumab pegol therapy. Results: Patients enrolled in PRECiSE 4 (N 310; mean age, 37 yr; 58% female; 95% white) had a mean Crohn's disease duration of 8.5 years before entering the qualifying studies. At weeks 52, 104, and 156, remission rates were 28.5%, 17.5%, and 12.6% by nonremitter imputation, and 63.8%, 60.0%, and 63.5% by observed cases, with 47.4%, 31.9%, and 23.2% of patients, respectively, remaining on therapy. By study end (7.5 yr), 92.3% of patients discontinued therapy, 49% on account of adverse events. No new safety signals emerged. Incidence rate (new cases)/100 patient-years was 6.11 for serious infections and 1.29 for malignancies. Conclusions: Certolizumab pegol was effective in many patients who previously discontinued certolizumab pegol for lack or loss of response. Thus, discontinuation of therapy may not always be necessary. Safety was consistent with previous findings.

Original languageEnglish (US)
Pages (from-to)1870-1880
Number of pages11
JournalInflammatory bowel diseases
Volume22
Issue number8
DOIs
StatePublished - May 31 2016

Fingerprint

Crohn Disease
Disease Progression
Safety
Therapeutics
Placebos
Certolizumab Pegol
Tumor Necrosis Factor-alpha
Incidence
Infection
Neoplasms

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Gastroenterology

Cite this

Lee, Scott D. ; Rubin, David T. ; Sandborn, William J. ; Randall, Charles ; Younes, Ziad ; Schreiber, Stefan ; Schwartz, David A. ; Burakoff, Robert ; Binion, David ; Dassopoulos, Themos ; Arsenescu, Razvan ; Gutierrez, Alexandra ; Scherl, Ellen ; Kayhan, Cem ; Hasan, Iram ; Kosutic, Gordana ; Spearman, Marshall ; Sen, David ; Coarse, Jason ; Hanauer, Stephen. / Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation : 7-Year Data from the PRECiSE 4 Study. In: Inflammatory bowel diseases. 2016 ; Vol. 22, No. 8. pp. 1870-1880.
@article{1dfb94e4291c4a34a87e81298856fd16,
title = "Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation: 7-Year Data from the PRECiSE 4 Study",
abstract = "Background: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. Methods: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks. We assessed safety (adverse events) and efficacy (clinical remission) of extended certolizumab pegol therapy. Results: Patients enrolled in PRECiSE 4 (N 310; mean age, 37 yr; 58{\%} female; 95{\%} white) had a mean Crohn's disease duration of 8.5 years before entering the qualifying studies. At weeks 52, 104, and 156, remission rates were 28.5{\%}, 17.5{\%}, and 12.6{\%} by nonremitter imputation, and 63.8{\%}, 60.0{\%}, and 63.5{\%} by observed cases, with 47.4{\%}, 31.9{\%}, and 23.2{\%} of patients, respectively, remaining on therapy. By study end (7.5 yr), 92.3{\%} of patients discontinued therapy, 49{\%} on account of adverse events. No new safety signals emerged. Incidence rate (new cases)/100 patient-years was 6.11 for serious infections and 1.29 for malignancies. Conclusions: Certolizumab pegol was effective in many patients who previously discontinued certolizumab pegol for lack or loss of response. Thus, discontinuation of therapy may not always be necessary. Safety was consistent with previous findings.",
author = "Lee, {Scott D.} and Rubin, {David T.} and Sandborn, {William J.} and Charles Randall and Ziad Younes and Stefan Schreiber and Schwartz, {David A.} and Robert Burakoff and David Binion and Themos Dassopoulos and Razvan Arsenescu and Alexandra Gutierrez and Ellen Scherl and Cem Kayhan and Iram Hasan and Gordana Kosutic and Marshall Spearman and David Sen and Jason Coarse and Stephen Hanauer",
year = "2016",
month = "5",
day = "31",
doi = "10.1097/MIB.0000000000000805",
language = "English (US)",
volume = "22",
pages = "1870--1880",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "John Wiley and Sons Inc.",
number = "8",

}

Lee, SD, Rubin, DT, Sandborn, WJ, Randall, C, Younes, Z, Schreiber, S, Schwartz, DA, Burakoff, R, Binion, D, Dassopoulos, T, Arsenescu, R, Gutierrez, A, Scherl, E, Kayhan, C, Hasan, I, Kosutic, G, Spearman, M, Sen, D, Coarse, J & Hanauer, S 2016, 'Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation: 7-Year Data from the PRECiSE 4 Study', Inflammatory bowel diseases, vol. 22, no. 8, pp. 1870-1880. https://doi.org/10.1097/MIB.0000000000000805

Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation : 7-Year Data from the PRECiSE 4 Study. / Lee, Scott D.; Rubin, David T.; Sandborn, William J.; Randall, Charles; Younes, Ziad; Schreiber, Stefan; Schwartz, David A.; Burakoff, Robert; Binion, David; Dassopoulos, Themos; Arsenescu, Razvan; Gutierrez, Alexandra; Scherl, Ellen; Kayhan, Cem; Hasan, Iram; Kosutic, Gordana; Spearman, Marshall; Sen, David; Coarse, Jason; Hanauer, Stephen.

In: Inflammatory bowel diseases, Vol. 22, No. 8, 31.05.2016, p. 1870-1880.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Reinduction with Certolizumab Pegol in Patients with Crohn's Disease Experiencing Disease Exacerbation

T2 - 7-Year Data from the PRECiSE 4 Study

AU - Lee, Scott D.

AU - Rubin, David T.

AU - Sandborn, William J.

AU - Randall, Charles

AU - Younes, Ziad

AU - Schreiber, Stefan

AU - Schwartz, David A.

AU - Burakoff, Robert

AU - Binion, David

AU - Dassopoulos, Themos

AU - Arsenescu, Razvan

AU - Gutierrez, Alexandra

AU - Scherl, Ellen

AU - Kayhan, Cem

AU - Hasan, Iram

AU - Kosutic, Gordana

AU - Spearman, Marshall

AU - Sen, David

AU - Coarse, Jason

AU - Hanauer, Stephen

PY - 2016/5/31

Y1 - 2016/5/31

N2 - Background: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. Methods: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks. We assessed safety (adverse events) and efficacy (clinical remission) of extended certolizumab pegol therapy. Results: Patients enrolled in PRECiSE 4 (N 310; mean age, 37 yr; 58% female; 95% white) had a mean Crohn's disease duration of 8.5 years before entering the qualifying studies. At weeks 52, 104, and 156, remission rates were 28.5%, 17.5%, and 12.6% by nonremitter imputation, and 63.8%, 60.0%, and 63.5% by observed cases, with 47.4%, 31.9%, and 23.2% of patients, respectively, remaining on therapy. By study end (7.5 yr), 92.3% of patients discontinued therapy, 49% on account of adverse events. No new safety signals emerged. Incidence rate (new cases)/100 patient-years was 6.11 for serious infections and 1.29 for malignancies. Conclusions: Certolizumab pegol was effective in many patients who previously discontinued certolizumab pegol for lack or loss of response. Thus, discontinuation of therapy may not always be necessary. Safety was consistent with previous findings.

AB - Background: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. Methods: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks. We assessed safety (adverse events) and efficacy (clinical remission) of extended certolizumab pegol therapy. Results: Patients enrolled in PRECiSE 4 (N 310; mean age, 37 yr; 58% female; 95% white) had a mean Crohn's disease duration of 8.5 years before entering the qualifying studies. At weeks 52, 104, and 156, remission rates were 28.5%, 17.5%, and 12.6% by nonremitter imputation, and 63.8%, 60.0%, and 63.5% by observed cases, with 47.4%, 31.9%, and 23.2% of patients, respectively, remaining on therapy. By study end (7.5 yr), 92.3% of patients discontinued therapy, 49% on account of adverse events. No new safety signals emerged. Incidence rate (new cases)/100 patient-years was 6.11 for serious infections and 1.29 for malignancies. Conclusions: Certolizumab pegol was effective in many patients who previously discontinued certolizumab pegol for lack or loss of response. Thus, discontinuation of therapy may not always be necessary. Safety was consistent with previous findings.

UR - http://www.scopus.com/inward/record.url?scp=84979879781&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84979879781&partnerID=8YFLogxK

U2 - 10.1097/MIB.0000000000000805

DO - 10.1097/MIB.0000000000000805

M3 - Article

VL - 22

SP - 1870

EP - 1880

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

IS - 8

ER -