Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice

Moon, Won; Pestana, Laura; Becker, Brenda D.; Loftus, Edward V.; Hanson, Karen A.; Kane, Sunanda V.

doi:10.1111/apt.13288

Cited by 16 publications

(10 citation statements)

References 33 publications

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“…In another study, a higher proportion of older patients [>60 years] discontinued due to infections and a lower proportion due to loss of response compared with younger patients [<60 years]) . Non‐compliance or poor compliance as a reason for discontinuation was considered only in two CD studies, showing that only a small proportion of patients discontinued directly due to a reason categorized as issues with compliance (0.5%‐3.0% of patients; studies did not define compliance adequately to determine whether these cases were driven by patient preference) …”

Section: Resultsmentioning

confidence: 99%

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Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

et al. 2019

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Summary What is known and objective The application of biologics to treat inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is well established. Our aim was to characterize the most recent five years of data on rates of adherence, persistence, switching and dose escalations with biologics used to treat IBD in the United States. Methods We systematically reviewed electronic databases MEDLINE, MEDLINE In‐Process, EMBASE and Cochrane Library for 2012‐2017 as well as conference proceedings for 2016‐2017 published in English. Results and discussion Of 449 records identified, 41 met all screening criteria. Published studies varied greatly in methodology, data sources, population studied, follow‐up time and endpoint definitions, preventing meaningful comparisons across studies. Based on studies using a medication possession rate threshold of <80% or <86%, 38%‐77% of patients were found non‐adherent to biologics. Discontinuation within the first 3 months occurred in 0%‐25% of patients in six studies; 7%‐65% discontinued by 12 months in 13 studies. Among all patients who initiated an index biologic, the switch rate to another biologic ranged from 4.5% to 20% in 6 studies. Dose escalations were reported in only four studies; 8%‐35% of patients had their dose escalated within the first year of therapy. What is new and conclusion This study demonstrates variability in study design and methodology to assess adherence, persistence, switching and dose escalation with biologics among adults with IBD in the United States. Our findings suggest that real‐world biologic use may be suboptimal and indicate new therapies and/or additional patient support may be needed.

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Section: Resultsmentioning

confidence: 99%

“…In addition, many patients experienced dose escalations. In the first year of therapy, 8%‐35% of patients experienced dose escalation of the index therapy (four studies) and 17%‐40% of patients experienced dose escalation within the first 2 years of index therapy (two studies) (Figure ).…”

Section: Resultsmentioning

confidence: 99%

Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

et al. 2019

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“…Recently, retrospective long-term data on the efficacy of CZP were reported and identified early age of CD manifestation, previous primary non-response to adalimumab, and presence of perianal fistulizing disease as negative predictors of response [36] . However, these patients represent a highly selected collective from a single large US tertiary referral center.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: The FACTS III Survey

Vavricka

Spasojevic

Rogler

et al. 2017

Dig Dis

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Background: Long-term data of certolizumab pegol (CZP) in Crohn's disease (CD) from pivotal registry trials are limited. We therefore aimed to evaluate the long-term efficacy of CZP in clinical practice in Switzerland. Methods: In the First Approved Certolizumab Therapeutic Experience in Switzerland-III phase IV multicenter cohort, patients receiving CZP were prospectively included all over Switzerland in (non-) academic hospitals and private practice. Results: We included 104 CD patients (52 male; only 22.1% anti-tumor necrosis factor (TNF) naïve, CZP as third anti-TNF agent in 46.2%) with follow-up time between 6 weeks up to 5 years. During treatment with CZP, we observed a significant decrease of the Harvey Bradshaw Index from a median of 7 at baseline (interquartile range 4-11) to 4, 5, 4, 3, 3, and 2 at weeks 6, 26, 52, 78, 104, and 156, respectively. While anti-TNF naïve patients showed a significantly better response at the end of induction, during CZP maintenance therapy response was similar as compared to anti-TNF experienced patients as well as between patients with a short (0-5 years) vs. long duration of disease (>5 years). Conclusions: CZP is an effective long-term treatment option, including CD patients with long disease duration and prior treatment with 1 or 2 anti-TNF agents.

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“…This also favors an increase in its half-life to two weeks. Results from some studies showed clinical benefits in patients refractory to other biological therapies [58]. Earlier studies showed more effectiveness when it is used as first-line agent [51].…”

Section: Anti-tnf-α Antibodies In Current Ibd Therapymentioning

confidence: 99%

Biological Treatments in Inflammatory Bowel Disease: A Complex Mix of Mechanisms and Actions

2021

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Inflammatory bowel disease (IBD) is a chronic disease that requires lifelong medication and whose incidence is increasing over the world. There is currently no cure for IBD, and the current therapeutic objective is to control the inflammatory process. Approximately one third of treated patients do not respond to treatment and refractoriness to treatment is common. Therefore, pharmacological treatments, such as monoclonal antibodies, are urgently needed, and new treatment guidelines are regularly published. Due to the extremely important current role of biologics in the therapy of IBD, herein we have briefly reviewed the main biological treatments currently available. In addition, we have focused on the mechanisms of action of the most relevant groups of biological agents in IBD therapy, which are not completely clear but are undoubtfully important for understanding both their therapeutic efficacy and the adverse side effects they may have. Further studies are necessary to better understand the action mechanism of these drugs, which will in turn help us to understand how to improve their efficacy and safety. These studies will hopefully pave the path for a personalized medicine.

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Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice

Abstract: SUMMARY BackgroundCertolizumab pegol (CZP) is Food and Drug Administration (FDA)-approved to treat Crohn's disease (CD). However, the efficacy and safety of CZP outside clinical trials are not well established.

Cited by 16 publications

References 33 publications

Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

Long-Term Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: The FACTS III Survey

Biological Treatments in Inflammatory Bowel Disease: A Complex Mix of Mechanisms and Actions

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