Andrew P. Yu

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

BACKGROUND & AIMS We determined the effects of adalimumab maintenance treatment on the risks of hospitalization and surgery in Crohns disease (CD). METHODS A total of 778 patients with CD were randomized to placebo, adalimumab 40 mg every other week or adalimumab 40 mg weekly, all after an 80-mg/40-mg adalimumab induction regimen. All-cause and CD-related hospitalizations and major CD-related surgeries were compared between the placebo and adalimumab groups (every other week, weekly, and both combined) using Kaplan-Meier analysis and Cox proportional hazard models. RESULTS Both 3- and 12-month hospitalization risks were significantly lower for patients who received adalimumab. Hazard ratios for all-cause hospitalization were 0.45, 0.36, and 0.40 for the adalimumab every other week, weekly, and combined groups, respectively (all P < .01 vs placebo). Hazard ratios for CD-related hospitalization were 0.50, 0.34, and 0.42, respectively (all P < .05). Cox model estimates demonstrated adalimumab every other week and weekly maintenance therapies were associated with 52% and 60% relative reductions in 12-month, all-cause hospitalization risk, and 48% and 64% reductions in 12-month risk of CD-related hospitalization. The combined adalimumab group was associated with 56% reductions in both all-cause and CD-related hospitalization risks. Fewer CD-related surgeries occurred in the adalimumab every other week, weekly, and combined groups compared with placebo (0.4, 0.8, and 0.6 vs 3.8 per 100 patients; all P < .05). CONCLUSIONS Patients with moderate-to-severe CD treated with adalimumab had lower 1-year risks of hospitalization and surgery than placebo patients.

The costs of Crohn's disease in the United States and other Western countries: a systematic review

ABSTRACT Objective: To conduct a critical and systematic literature review of the costs of Crohns disease (CD) in Western industrialized countries. Research design and methods: Studies published in English that described the cost of CD in Western industrialized countries were identified using three major databases (Medline, EMBASE, and ISI Web of Science). Studies were reviewed and rated based on their relevance to cost of illness and the reliability of the estimates. All costs were adjusted for inflation to 2006 values. Results: Estimated direct medical costs were

Systematic review: the costs of ulcerative colitis in Western countries

18 022–18 932 per patient with CD per year in the United States, and €2898–6960 in other Western countries. Hospitalizations accounted for 53–66% of direct medical costs, with an average cost-per-hospitalization of

The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn’s disease who failed prior infliximab therapy

37 459 in the United States. Estimated indirect costs accounted for 28% of the total cost in the United States and 64–69% in Europe. Costs differed greatly by disease severity. Costs of patients with severe disease were 3- to 9-fold higher than patients in remission. Direct medical costs in the United States for patients in the top 25% of total costs averaged

Comparative Effectiveness Without Head-to-Head Trials: A Method for Matching-Adjusted Indirect Comparisons Applied to Psoriasis Treatment with Adalimumab or Etanercept

60 582 per year; costs of patients in the top 2% averaged more than

The effect of adalimumab on reducing depression symptoms in patients with moderate to severe psoriasis: A randomized clinical trial

300 000 per year. Combining prevalence rates, the total economic burden of CD was

Risks of developing psychiatric disorders in pediatric patients with psoriasis

10.9–15.5 billion in the United States and €2.1–16.7 billion in Europe. Limitations: This review is limited by the research quality and variations of the individual studies reviewed, and only includes English articles. Conclusions: This updated literature synthesis demonstrated the substantial total cost burden of CD, of which hospitalizations accounted for more than half of direct medical costs.

Economic burden of comorbidities in patients with psoriasis is substantial.

Aliment Pharmacol Ther 31, 693–707

Coronary Heart Disease and Stroke Risk in Patients with Psoriasis: Retrospective Analysis

Aliment Pharmacol Ther 2010; 32: 1228–1239

Comparison of two adalimumab treatment schedule strategies for moderate-to-severe Crohn's disease: results from the CHARM trial.

The absence of head-to-head trials is a common challenge in comparative effectiveness research and health technology assessment. Indirect cross-trial treatment comparisons are possible, but can be biased by cross-trial differences in patient characteristics. Using only published aggregate data, adjustment for such biases may be impossible. Although individual patient data (IPD) would permit adjustment, they are rarely available for all trials. However, many researchers have the opportunity to access IPD for trials of one treatment, a new drug for example, but only aggregate data for trials of comparator treatments. We propose a method that leverages all available data in this setting by adjusting average patient characteristics in trials with IPD to match those reported for trials without IPD. Treatment outcomes, including continuous, categorical and censored time-to-event outcomes, can then be compared across balanced trial populations.The proposed method is illustrated by a comparison of adalimumab and etanercept for the treatment of psoriasis. IPD from trials of adalimumab versus placebo (n = 1025) were re-weighted to match the average baseline characteristics reported for a trial of etanercept versus placebo (n = 330). Reweighting was based on the estimated propensity of enrolment in the adalimumab versus etanercept trials. Before matching, patients in the adalimumab trials had lower mean age, greater prevalence of psoriatic arthritis, less prior use of systemic treatment or phototherapy, and a smaller mean percentage of body surface area affected than patients in the etanercept trial. After matching, these and all other available baseline characteristics were well balanced across trials. Symptom improvements of ≥75% and ≥90% (as measured by the Psoriasis Area and Severity Index [PASI] score at week 12) were experienced by an additional 17.2% and 14.8% of adalimumab-treated patients compared with the matched etanercept-treated patients (respectively, both p < 0.001). Mean percentage PASI score improvements frombaseline were also greater for adalimumab than for etanercept at weeks 4, 8 and 12 (all p < 0.05). Matching adjustment ensured that this indirect comparison was not biased by differences in mean baseline characteristics across trials, supporting the conclusion that adalimumab was associated with significantly greater symptom reduction than etanercept for the treatment of moderate to severe psoriasis.