Anthony Wang

Anti–Tumor Necrosis Factor Therapy and Incidence of Parkinson Disease Among Patients With Inflammatory Bowel Disease

Importance Despite established genetic and pathophysiologic links between inflammatory bowel disease (IBD) and Parkinson disease (PD), clinical data supporting this association remain scarce. Although systemic inflammation is considered a potential biological mechanism shared between the 2 diseases, the role of reduced systemic inflammation through IBD-directed anti–tumor necrosis factor (anti-TNF) therapy in PD risk is largely unknown. Objective To compare the incidence of PD among individuals with or without IBD and to assess whether PD risk among patients with IBD is altered by anti-TNF therapy. Design, Setting, and Participants This is a retrospective cohort study analyzing information in the Truven Health MarketScan administrative claims database and the Medicare Supplemental Database between January 1, 2000, and March 31, 2016. Individuals were selected who had at least 2 claims for IBD diagnoses, at least 6 months of follow-up, and no prior diagnosis of PD on or before the IBD index date. Exposure to Anti-TNF therapy was measured from the anti-TNF index date to the last date of anti-TNF coverage or the end of enrollment or PD index date, whichever was earliest. Incidence rates per 1000 person-years were calculated, and crude and adjusted incidence rate ratios were estimated by Poisson regression models and presented with 95% CIs. Main Outcomes and Measures Incidence of PD among patients with IBD with or without exposure to anti-TNF therapy. Results In total, 144 018 individuals with IBD were matched on age, sex, and year of index date with 720 090 unaffected controls. Of them, 1796 individuals had at least 2 PD diagnoses and at least 1 filled PD-related prescription. The mean (SD) age of individuals with IBD was 51 (17) years, and 44% were men. The incidence of PD among patients with IBD was 28% higher than that among unaffected matched controls (adjusted incidence rate ratio, 1.28; 95% CI, 1.14-1.44; P < .001). A 78% reduction in the incidence rate of PD was detected among patients with IBD who were exposed to anti-TNF therapy compared with those who were not exposed (adjusted incidence rate ratio, 0.22; 95% CI, 0.05-0.88; P = .03). Conclusions and Relevance A higher incidence of PD was observed among patients with IBD than among individuals without IBD. Early exposure to antiinflammatory anti-TNF therapy was associated with substantially reduced PD incidence. These findings support a role of systemic inflammation in the pathogenesis of both diseases. Further studies are required to determine whether anti-TNF treatment administered to high-risk individuals may mitigate PD risk.

Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States

Abstract Objective: We compared the real-world effectiveness of initiating adalimumab and infliximab among patients in the US who were naïve to tumor necrosis factor (TNF) inhibitors. Methods: A retrospective chart review was conducted to evaluate the real-world effectiveness among adults with ulcerative colitis (UC) initiating adalimumab or infliximab. Charts of patients with UC were abstracted by treating physicians (randomly selected from a nationally representative panel) in April 2014. Patient eligibility criteria included: adalimumab or infliximab initiation on/after 1 October 2012; no prior anti-TNF therapy, history of Crohn’s disease, or colectomy; and ≥6 months of follow-up. Information on clinical outcomes (partial Mayo score, remission rate, physician global assessment (PGA), stool frequency, and rectal bleeding) and treatment patterns (dose escalations, discontinuations, switches, and treatment augmentations) were retrospectively reported by treating physicians. Kaplan–Meier curves and multivariate Cox proportional hazards regression models were used to assess the time to clinical outcomes and treatment changes for each therapy. Results: Overall, 170 physicians participated, contributing data on 380 and 424 patients who initiated adalimumab and infliximab, respectively. Baseline clinical characteristics were similar between groups. Both adalimumab- and infliximab-treated patients showed substantial improvements from baseline to follow-up in effectiveness measures; results of these measures were similar between the adalimumab and infliximab cohorts. Time to remission (p = 0.5241), no rectal bleeding (p = 0.7648), normal stool count (p = 0.9941), and normal PGA (p = 0.7697) showed no significant differences between therapies in unadjusted and adjusted comparisons. Unadjusted and adjusted time to event analysis of discontinuation (p = 0.7151), dose escalation (p = 0.6310), treatment augmentation (p = 0.1209), and switching (p = 0.7975) showed no significant differences between the two cohorts. Limitations: Retrospective, observational design. Conclusions: Adalimumab and infliximab were similarly effective in the treatment of moderate-to-severe UC in the real-world clinical setting.

Costs of providing infusion therapy for patients with inflammatory bowel disease in a hospital-based infusion center setting

Abstract Aims: Inflammatory bowel disease (IBD) (e.g. ulcerative colitis [UC] and Crohn’s disease [CD]) severely impacts patient quality-of-life. Moderate-to-severe disease is often treated with biologics requiring infusion therapy, adding incremental costs beyond drug costs. This study evaluates US hospital-based infusion services costs for treatment of UC or CD patients receiving infliximab or vedolizumab therapy. Materials and methods: A model was developed, estimating annual costs of providing monitored infusions using an activity-based costing framework approach. Multiple sources (published literature, treatment product inserts) informed base-case model input estimates. Results: The total modeled per patient infusion therapy costs in Year 1 with infliximab and vedolizumab was

Comparison of Health Care Utilization and Costs Between Patients with Perianal Fistulizing Crohnʼs Disease Treated with Biologics with or Without Previous Seton Placement

38,782 and

Mo1791 Adalimumab Treatment Reduces Extraintestinal Manifestations in Patients With Moderate to Severe Crohn's Disease: A Pooled Analysis

41,320, respectively, and Year 2+,

Impact of Diagnostic Delay and Associated Factors on Clinical Outcomes in a U.S. Inflammatory Bowel Disease Cohort

49,897 and

Indirect Costs and Family Burden of Pediatric Crohnʼs Disease in the United States

36,197, respectively. Drug acquisition cost was the largest total costs driver (90–93%), followed by costs associated with hospital-based infusion provision: labor (53–56%, non-drug costs), allocated overhead (23%, non-drug costs), non-labor (23%, non-drug costs), and laboratory (7–10%, non-drug costs). Limitations: Limitations included reliance on published estimates, base-case cost estimates infusion drug, and supplies, not accounting for volume pricing, assumption of a small hospital infusion center, and that, given the model adopts the hospital perspective, costs to the patient were not included in infusion administration cost base-case estimates. Conclusions: This model is an early step towards a framework to fully analyze infusion therapies’ associated costs. Given the lack of published data, it would be beneficial for hospital administrators to assess total costs and trade-offs with alternative means of providing biologic therapies. This analysis highlights the value to hospital administrators of assessing cost associated with infusion patient mix to make more informed resource allocation decisions. As the landscape for reimbursement changes, tools for evaluating the costs of infusion therapy may help hospital administrators make informed choices and weigh trade-offs associated with providing infusion services for IBD patients.

Extraintestinal Manifestations in Vedolizumab and Anti-TNF-Treated Patients With Inflammatory Bowel Disease

Background: Fistulas are a common and often debilitating complication of Crohns disease (CD). Tumor necrosis factor inhibitors and/or seton drainage are effective treatment options. We compared health care utilization and costs for patients with perianal CD who had setons placed before treatment with biologics versus those who did not. Methods: Patients with CD (≥18 yr) were identified from the Truven Health MarketScan Database by ICD-9 code 555.x (January 1, 2006–March 31, 2015); those with external fistulas were identified by ICD-9 codes 565.1. Biological treatment and seton procedures were identified with the National Drug Codes or Current Procedural Terminology codes. Patients were grouped into 2 cohorts: seton before biological (SBB) treatment or no seton before biological (NSBB) treatment. Results: SBB (N = 326) and NSBB (N = 1519) groups were similar in baseline age, sex, use of immunosuppressants and steroids, and comorbidity score. Baseline prevalence of asthma and cardiovascular disease, and use of antibiotics and 5-aminosalicylic acid were significantly greater in the SBB group versus the NSBB group. Baseline number of all-cause and fistula-related hospitalizations were greater for the SBB group than in the NSBB group. However, during follow-up, the NSBB group required significantly more hospitalizations than the SBB group (all-cause: 0.41 versus 0.23; fistula related: 0.16 versus 0.07) and had significantly greater health care costs (all-cause:

P144 ECONOMIC IMPACT OF SWITCHING FROM ANTI-TNF THERAPY TO ADALIMUMAB, INFIXIMAB OR OTHER ANTI-TNF COMPARED WITH SWITCHING FROM ANTI-TNF THERAPY TO VEDOLIZUMAB

9711 versus

Sa1720 - The Impact of Intestinal Complications on Healthcare Costs Among Inflammatory Bowel Disease Patients with Anti-TNF Therapies

5514; fistula related: