{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T11:48:23Z","timestamp":1753876103626,"version":"3.41.2"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T00:00:00Z","timestamp":1737763200000},"content-version":"vor","delay-in-days":26,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"UCB Pharma and Ferring Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Crohn\u2019s disease (CD) treatment is associated with increased risks of infection and malignancies. Although the safety of certolizumab pegol (CZP) is well established, long-term data from community-based observational studies are lacking.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>This study aimed to evaluate long-term safety outcomes of patients from the SECURE registry receiving CZP relative to other CD treatments, including corticosteroids, immunosuppressants, and biologics. The primary outcome of this observational study was the evaluation of malignancies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adult patients with CD were prospectively monitored for up to 8 years. Pre-specified data were collected for all enrolled patients. Adverse events of interest (AEoIs) were reported per 100 patient-years (PY) of exposure. Incidence rate ratios (IRRs) were calculated for AEoIs using multivariate regression analysis accounting for exposure to multiple treatments. Malignancies reported after any exposure to CZP were attributed to CZP. Post-hoc analyses were conducted to evaluate non-melanoma skin cancer (NMSC), lymphoma, and pregnancy outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 3072 patients were enrolled in the study. The risk of AEoIs was similar between patients with only CZP exposure versus comparator exposure. Among patients with any CZP exposure, there was a higher frequency of serious infections (IRR: 2.56 [95% confidence interval (CI): 2.00, 3.29]) and hypersensitivity or anaphylactic reactions (IRR: 4.11 [95% CI: 1.80, 9.38]) versus patients with comparator exposure. Malignancy rates were similar across groups; however, concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]). Most cases of lymphoma (5\/7) occurred in patients with exposure to thiopurines. Pregnancy outcomes were similar across groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>No new safety signals were identified for CZP; the use of thiopurines was identified as a risk factor for NMSC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>NCT00844285.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/crocol\/otae083","type":"journal-article","created":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T12:38:06Z","timestamp":1737808686000},"source":"Crossref","is-referenced-by-count":0,"title":["Certolizumab Pegol Treatment in Patients With Crohn\u2019s Disease: Final Safety Data From the SECURE Registry"],"prefix":"10.1093","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0815-2044","authenticated-orcid":false,"given":"Gary R","family":"Lichtenstein","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology,\u00a0University of Pennsylvania School of Medicine , Philadelphia, PA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott D","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology,\u00a0University of Washington School of Medicine , Seattle, WA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6914-3822","authenticated-orcid":false,"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"University of Western\u00a0Ontario,\u00a0Robarts Research Institute at Schulich School of Medicine and\u00a0Dentistry , London, Ontario ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr.","given":"Edward V","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology,\u00a0Mayo Clinic College of Medicine and Science , Rochester, MN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4494-2182","authenticated-orcid":false,"given":"Samson","family":"Ng","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals , Parsippany, NJ ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaitlin","family":"Dehlin","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals , Parsippany, NJ ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Quinn","sequence":"additional","affiliation":[{"name":"PQ Clinical Consulting , London ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Coarse","sequence":"additional","affiliation":[{"name":"UCB , Morrisville, NC ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theresa","family":"Rosario-Jansen","sequence":"additional","affiliation":[{"name":"UCB , Morrisville, NC ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Arendt","sequence":"additional","affiliation":[{"name":"UCB , Brussels ,","place":["Belgium"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey L","family":"Stark","sequence":"additional","affiliation":[{"name":"UCB , Smyrna, GA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,1,25]]},"reference":[{"issue":"8","key":"2025020109453757500_CIT0001","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1002\/14651858.CD012893.pub2","article-title":"Certolizumab pegol for induction of remission in Crohn\u2019s 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