Cost-effectiveness of biological treatment of ulcerative colitis – a systematic review

Stawowczyk, Ewa; Kawalec, Paweł

doi:10.5114/pg.2017.68166

Cited by 3 publications

(2 citation statements)

References 28 publications

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“…Over the past decade, biologics have significantly changed the management of inflammatory Crohn’s disease (CD) 1 and ulcerative colitis (UC) 2 . However, access to treatment with biologics is frequently limited by their high cost 3 . The introduction of less costly biosimilars may increase patient access to well-established therapies while improving healthcare affordability, which is particularly important in lower GDP countries.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Gheorghe

Svoboda

Mateescu

2019

Journal of Drug Assessment

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Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn’s disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn’s Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD ( n = 38) or UC ( n = 47) received biosimilar infliximab for up to 30 weeks. Most patients ( n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8–78.9) of CD patients and 55.3% (95% CI = 41.2–68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5–62.7) and 48.9% (95% CI = 35.3–62.8), respectively, were in remission. Statistically significant ( p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved ( p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

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Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Gheorghe

Svoboda

Mateescu

2019

Journal of Drug Assessment

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“…Ulcerative colitis (UC) is an inflammatory bowel disease that increases the risk of colon cancer as well as significantly alters the quality and lifestyle of people within the age range of 20-50 years [1]. Many current research studies are the pathogenesis and treatment of UC, which generally emphasize that it is essential to control the disease [2].…”

Section: Introductionmentioning

confidence: 99%

Preventative effects of Lactobacillus plantarum YS-3 on oxazolone-induced BALB/c colitis in mice

Xia

Zhang²,

Qian

et al. 2018

Appl Biol Chem

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In this study, the preventative effects of Lactobacillus plantarum YS-3 (LP-YS3) on colitis were studied using an in vitro animal experiment. Oxazolone was administered to BALB/c mice to induce colitis, and the preventive effects of LP-YS3 were determined using serum-and tissue-related indexes. The mice treated with LP-YS3 showed a significant decrease (p \ 0.05) in disease activity index for colitis by inhibiting colon shortening and increasing colon weight/length ratio. The application of LP-YS3 resulted in a significant reduction in myeloperoxidase, nitric oxide, and malondialdehyde activities and a decrease in glutathione activity (p \ 0.05) in mouse colon tissues. LP-YS3 also significantly increased serum interleukin-2 and reduced interleukin-10 cytokines levels in mice (p \ 0.05). Reverse transcription-polymerase chain reaction and western blot assays showed that LP-YS3 application resulted in a significant increase in neuronal nitric oxide synthase, endothelial nitric oxide synthase, c-Kit, and stem cell factor expressions and a decrease in inducible nitric oxide synthase, interleukin-8, and C-X-C motif chemokine receptor 2 expressions in mouse colonic tissues (p \ 0.05). These findings indicate that LP-YS3 imparts preventative effects on oxazoloneinduced colitis in mice. Keywords Lactobacillus plantarum YS-3 Á Oxazolone Á Colitis Á Chemokine receptor Á Expression Xia Feng and Jing Zhang have contributed equally to this work.

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The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis

Kaniewska¹,

Moniuszko²,

Rydzewska³

2017

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IntroductionThe biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC).AimTo assess the efficacy and safety of the biosimilar product Inflectra® in comparison with its reference biological agent (Remicade®) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment.Material and methodsIn a single-centre retrospective study, a cohort of 83 adult patients with severe UC treated at the Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision of the Central Clinical Hospital of MSWiA, Warsaw was investigated. All patients received three induction doses of Remicade® (28 individuals) or Inflectra® (55 individuals) based on the same criteria of the National Health Fund (NFZ) Therapeutic Program (total Mayo score > 6). Activity of the disease was evaluated on the Mayo scale at qualification, after finishing the rescue treatment (after 14 weeks), and after a 6-month observation period. In all patients, sigmoidoscopy was performed at qualification and after induction (after three doses).ResultsThe studied groups were similar with respect to age and sex distribution, duration of the disease, extent of the disease (left-sided type, pancolitis), additional pharmacotherapy, and smoking. Clinical response following three induction doses was noted in 81% of patients receiving Remicade® compared to 77% receiving the biosimilar product, Inflectra® (NS); while clinical remission was observed in 42% receiving Remicade® and 32% receiving Inflectra® (NS), respectively. Endoscopic remission assessed as 0 on the Mayo scale was achieved in 4 (15%) patients on Remicade® and in 7 (13%) patients on Inflectra® (p = 0.45). Relapse occurred in 68% of all patients, while 51% presented with exacerbation of the disease 3 months after finishing biological treatment. In 93%, exacerbation occurred within 12 months. The recurrence rate was similar in both groups (75% with Remicade®, 64% with Inflectra®, respectively). Side effects occurred with similar frequency in both groups.ConclusionsIn the study, it was established that the biosimilar drug (Inflectra®) has a similar efficacy and safety as the reference biological agent (Remicade®), not only in rescue therapy, but also during a 6-month observation period in adult patients with severe UC. Low mucosal healing rate in both groups and high recurrence rate of the disease soon after finishing induction treatment indicate the need for prolonged therapy with infliximab in patients with severe UC.

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Cost-effectiveness of biological treatment of ulcerative colitis – a systematic review

Cited by 3 publications

References 28 publications

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

Preventative effects of Lactobacillus plantarum YS-3 on oxazolone-induced BALB/c colitis in mice

The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis

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