The Magnitude of Crohn’s Disease Direct Costs in Health Care Systems (from Different Perspectives): A Systematic Review

Santiago, Mafalda; Dias, Cláudia Camila; Alves, Catarina; Ministro, Paula; Gonçalves, Raquel; Carvalho, Diana; Portela, Francisco; Correia, Luís; Lago, Paula; Magro, Fernando

doi:10.1093/ibd/izab334

Cited by 7 publications

(9 citation statements)

References 52 publications

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“…costs. [29][30][31][32] With healthcare costs continuing to rise, biosimilars have the potential to improve access to biologics by providing less expensive treatment options with safety and efficacy profiles comparable to their RPs. 5,6 This study demonstrated PK equivalency in healthy volunteers following a single 90 mg SC injection of ABP 654, ustekinumab US, or ustekinumab EU.…”

Section: Discussionmentioning

confidence: 99%

“…The effectiveness of ustekinumab RP to control disease progression of patients with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis is well established 22–28 ; however, these conditions are associated with significant treatment costs 29–32 . With healthcare costs continuing to rise, biosimilars have the potential to improve access to biologics by providing less expensive treatment options with safety and efficacy profiles comparable to their RPs 5,6 …”

Section: Discussionmentioning

confidence: 99%

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Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects

Chow

Mytych

Das

et al. 2023

Clinical Pharm in Drug Dev

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ABP 654 is a proposed biosimilar to ustekinumab reference product (RP) which works through antagonism of interleukin‐12 and interleukin‐23. Ustekinumab RP is used for the treatment of chronic inflammatory conditions, including some forms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. A randomized, double‐blinded, single‐dose, 3‐arm, parallel‐group study was conducted to assess the pharmacokinetic (PK) similarity of ABP 654 with ustekinumab RP sourced from the United States (US) and the European Union (EU); the PK similarity of ustekinumab US versus ustekinumab EU; and the comparative safety, tolerability, and immunogenicity of all 3 products. A total of 238 healthy subjects were randomized 1:1:1 and stratified by gender and ethnicity (Japanese versus non‐Japanese) to receive a single 90 mg subcutaneous injection of ABP 654 or ustekinumab US or ustekinumab EU. PK similarity was established based on 90% confidence intervals (CIs) for the primary endpoints of area under the concentration‐time curve from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) being contained within the prespecified margin of 0.8–1.25. No clinically meaningful differences in immunogenicity were found among the 3 products. Adverse events were similar between treatment groups and consistent with the safety profile of ustekinumab RP. Results indicate that ABP 654, ustekinumab US and ustekinumab EU share similar PK and safety profiles.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects

Chow

Mytych

Das

et al. 2023

Clinical Pharm in Drug Dev

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“…In this sense, it would be very useful to develop international registries involving several countries currently experiencing a clear increase in the incidence of IBD, such as Latin America and Asia, and which have greater difficulty in accessing advanced treatments[ 50 - 52 ]. In this regard, the costs associated with dual therapy are the main limitation to access, which restrict the provision of a personalized treatment in patients with indication for this strategy[ 53 ]. Moreover, it is of great relevance to inform the health insurance of these patients about the objectives and advantages of the dual therapy strategy to obtain the appropriate approval in a timely manner for the indication.…”

Section: New Horizonsmentioning

confidence: 99%

Role of the combination of biologics and/or small molecules in the treatment of patients with inflammatory bowel disease

Balderramo¹

2022

World J Gastroenterol

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Inflammatory bowel disease (IBD) is a group of chronic diseases that includes ulcerative colitis, Crohn’s disease, and indeterminate colitis. Patients with IBD require prolonged treatment and high utilization of healthcare resources for proper management. The treatment of patients with IBD is focused on achieving therapeutic goals including clinical, biochemical, and endoscopic variables that result in improvement of the quality of life and prevention of disability. Advanced IBD treatment includes tumor necrosis factor inhibitors, integrin antagonist, antagonist of the p40 subunit of interleukin 12/23, and small molecule drugs. However, despite the multiple treatments available, about 40% of patients are refractory to therapy and present with persistent symptoms that have a great impact on their quality of life, with hospitalization and surgery being necessary in many cases. Dual therapy, a strategy sometimes applicable to refractory IBD patients, includes the combination of two biologics or a biologic in combination with a small molecule drug. There are two distinct scenarios in IBD patients in which this approach can be used: (1) Refractory active luminal disease without extraintestinal manifestations; and (2) patients with IBD in remission, but with active extraintestinal manifestations or immune-mediated inflammatory diseases. This review provides a summary of the results (clinical response and remission) of different combinations of advanced drugs in patients with IBD, both in adults and in the pediatric population. In addition, the safety profile of different combinations of dual therapy is analyzed. The use of newer combinations, including recently approved treatments, the application of new biomarkers and artificial intelligence, and clinical trials to establish effectiveness during long-term follow-up, are needed to establish new strategies for the use of advanced treatments in patients with refractory IBD.

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“…Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract with a remitting and relapsing course, 1 and substantial implications for the lives of patients, [2][3][4] as well as a considerable economic impact on society. 5 Current management strategies and therapies focus on reducing inflammatory burden in patients with active disease and maintaining remission in those with inactive disease. Over the last 20 years the efficacy of multiple novel drugs in inducing remission of active CD has been evaluated, mostly in randomized controlled trials (RCTs) versus a placebo.…”

Section: Introductionmentioning

confidence: 99%

Impact of Baseline Disease Activity and Trial Duration on Efficacy of Biologics in Active Crohn’s Disease: Meta-analysis

Barberio

Gracie

Black

et al. 2023

Inflammatory Bowel Diseases

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Background Timings of assessment of efficacy and criteria used to define Crohn’s disease (CD) activity at baseline may affect therapeutic gain of active drug over placebo in induction of remission trials in CD, but these issues have not been assessed systematically. We examined these issues in a meta-analysis. Methods We searched the literature to June 2022 for randomized controlled trials of biologics vs placebo in active CD. We extracted clinical remission and response rates according to criteria used to define CD activity and time point of assessment, pooling them in a meta-analysis for all patients according to previous biologic exposure. We calculated the number needed to treat (NNT), with a 95% confidence interval (CI) to assess therapeutic gain of active drug over placebo according to these characteristics of trial design. Results We identified 20 induction of remission trials (6754 patients). Rates of clinical remission were highest (42.6% with active drug vs 21.0% with placebo) and NNT lowest (5; 95% CI, 3-7.5) in trials using clinical and endoscopic activity to define active CD. Rates of remission were lower (26.5% with active drug, vs 18.6% with placebo) and NNT highest (12; 95% CI, 6-61) in trials using clinical activity alone. Results were similar according to previous biologic exposure. Time point of assessment seemed to have less of an effect, although the NNT was lowest in trials assessing remission rates at 9 to 12 weeks (NNT = 5.5; 95% CI, 4-8). Again, results were similar according to previous biologic exposure. Conclusions Both the criteria used to define CD activity at study entry and the time point used to confirm efficacy may be important in maximizing therapeutic gain of active drug over placebo.

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The Magnitude of Crohn’s Disease Direct Costs in Health Care Systems (from Different Perspectives): A Systematic Review

Cited by 7 publications

References 52 publications

Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects

Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects

Role of the combination of biologics and/or small molecules in the treatment of patients with inflammatory bowel disease

Impact of Baseline Disease Activity and Trial Duration on Efficacy of Biologics in Active Crohn’s Disease: Meta-analysis

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