Effects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease: Results From the CHARM Study

Feagan, Brian G.; Panaccione, Remo; Sandborn, William J.; D’Haens, Geert R.; Schreiber, Stefan; Rutgeerts, Paul; Loftus, Edward V.; Lomax, Kathleen G.; Yu, Andrew P.; Wu, Eric Q.; Chao, Jingdong; Mulani, Parvez

doi:10.1053/j.gastro.2008.07.069

Cited by 340 publications

(208 citation statements)

References 21 publications

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“…They have long‐standing proven efficacy in inducing and maintaining remission in IBD 1, 2. However, for some patients response can be suboptimal, and primary loss of response (LOR) at the end of induction phase of anti‐TNFα therapy can have significant implications for patients.…”

Section: Introductionmentioning

confidence: 99%

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

et al. 2017

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Background and AimAnti‐tumor necrosis factor alpha (TNFα) therapies have improved outcomes for patients with inflammatory bowel disease. The aim of this study was to explore the relationship between infliximab (IFX) and adalimumab (ADL) trough and antibody levels with clinical response rates at the end of induction.MethodsThis was a prospective, single‐center study. Patients were recruited from July 2015 to August 2016. Inclusion criteria were all inflammatory bowel disease patients older than 17 years who started treatment with IFX or ADL. Baseline clinical disease activity indexes were performed. Clinical response was defined as HBI ≤3 or partial Mayo score ≤4% or <30% reduction from baseline. Anti‐TNFα trough and antibody levels were measured using standard ELISA techniques.ResultsThirty‐five patients were recruited, of whom 23 had Crohn's disease and 12 had ulcerative colitis. Eighteen were treated with ADL and 17 with IFX. The mean age of the cohort was 40.3 years, 62.9% were females, 34.3% were on concomitant thiopurines, and 25.7% had prior anti‐TNFα exposure. Overall response rate was 51.4%, 33.3% for ADL and 70.6% for IFX.Mean trough levels were 12.5 μg/mL for IFX and 4.4 μg/mL for ADL. There was a clear link between higher anti‐TNFα trough levels at the end of induction with clinical response rates. For IFX, mean trough level was 16.4 μg/mL for responders versus 5.3 μg/mL for non‐responders (P = 0.026). Area under the curve for association of IFX level at induction with clinical response was 0.864 (P = 0.0001). Similar link was present between higher ADL levels with clinical response, although not statistically significant.ConclusionHigher trough levels at the end of induction are associated with improved response. Ongoing work will define optimal targets at this key timeframe.

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Section: Introductionmentioning

confidence: 99%

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

et al. 2017

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“…The probability of surgical remission was obtained from Siverstein et al's study (Silverstein et al, 1999) and adapted for the model cycle duration. The probability for a patient with active disease to proceed to the surgery state estimated is 0.45% per cycle (Feagan et al, 2008). Based on this same study (Feagan et al, 2008), hospitalization probability is established at 1.9% in patients with drug treatment failure.…”

Section: Transition Probabilitiesmentioning

confidence: 92%

“…The probability for a patient with active disease to proceed to the surgery state estimated is 0.45% per cycle (Feagan et al, 2008). Based on this same study (Feagan et al, 2008), hospitalization probability is established at 1.9% in patients with drug treatment failure. In addition, the relative risks and respective response ratios are presented in Table 2.…”

Section: Transition Probabilitiesmentioning

confidence: 92%

Cost-minimization and budget impact analysis of certolizumab pegol for patients with Crohn’s disease, moderate or severe, with relapse after conventional treatment from the perspective of the Brazilian private payer

Rosim¹,

Duva²,

Ferraz³

et al. 2017

JBES

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Objectives: Budget impact and cost-effectiveness analysis are often required by payers when discussing drug reimbursement. We hereby present a cost-minimization (CMA) and budget impact analysis (BIA) regarding the incorporation of certolizumab pegol (CZP) for the treatment of patients with Crohn's disease, a debilitating condition that affects the digestive tract. Methods: Considering that the scientific literature demonstrates CZP as effective as the alternatives (infliximab and adalimumab), a CMA was conducted, including a Markov 10-year time horizon modeling. Focusing on the assumptions for both CMA and BIA, a total of 36 stakeholders from the private sector were surveyed regarding treatment and disease-related costs. For the BIA, drug acquisition costs, administration costs, no population growth and an immunobiologic drug (bDMARD) switching rate of 5% were also considered. We assumed that CZP would gradually gain market share until it reaches 20% of new or switching patients in the fourth year. In addition, probability sensitivity analyses were performed. Results: In the cost-minimization, the calculated costs for 10-year treatment were BRL149k (infliximab); BRL118k (adalimumab) and BRL83k (CZP). Probabilistic sensitivity analysis was conducted with 1,000 random simulations, with CZP being less costly than its comparators in all simulations. Additionally, the BIA result indicates that CZP is a cost-saving intervention, with a predicted five-year impact of BRL317k for every 100-patient cohort. Conclusions: Certolizumab pegol was shown to be not only effective but also a cost-saving drug when compared to other anti-TNF drugs available for the Brazilian private healthcare system. RESUMOObjetivos: Análises de impacto orçamentário e de custo-efetividade são, com frequência, exigidas por pagadores para a decisão sobre incorporação de drogas. Por esse motivo, apresentaremos uma análise de custo-minimização e de impacto orçamentário do certolizumabe pegol (CZP) para o tratamento de pacientes com doença de Crohn, doença crônica e debilitante que afeta o trato digestivo. Métodos: Trinta e seis pagadores privados foram entrevistados para que fosse possível

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“…To achieve this final sample size, it was necessary to recruit 132 patients into the study based on an attrition rate between 25% and 36% observed in the CHARM study (24).…”

Section: Methodsmentioning

confidence: 99%

Clinical status, quality of life, and work productivity in Crohns disease patients after one year of treatment with adalimumab

et al. 2016

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Objective: Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice.Material and methods: This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p < 0.05. Results:The sample was composed of 126 patients (age Conclusions: In regular practice, adalimumab is clinically effective in the treatment of Crohn's disease patients and results in a significant improvement in quality of life and work productivity.

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Effects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease: Results From the CHARM Study

Cited by 340 publications

References 21 publications

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

Cost-minimization and budget impact analysis of certolizumab pegol for patients with Crohn’s disease, moderate or severe, with relapse after conventional treatment from the perspective of the Brazilian private payer

Clinical status, quality of life, and work productivity in Crohns disease patients after one year of treatment with adalimumab

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Effects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease: Results From the CHARM Study

Cited by 340 publications

References 21 publications

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

Positive relationship between infliximab and adalimumab trough levels at completion of induction therapy with clinical response rates, at a tertiary referral center

Cost-minimization and budget impact analysis of certolizumab pegol for patients with Crohn’s disease, moderate or severe, with relapse after conventional treatment from the perspective of the Brazilian private payer

Clinical status, quality of life, and work productivity in Crohns disease patients after one year of treatment with adalimumab

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Clinical status, quality of life, and work productivity in Crohns disease patients after one year of treatment with adalimumab