Candace L. Beilman

Anti-TNF Therapy Within 2 Years of Crohn's Disease Diagnosis Improves Patient Outcomes: A Retrospective Cohort Study.

Background:Although biological agents targeting tumor necrosis factor (TNF) alpha are effective in the management of Crohns disease (CD), use of anti-TNF agents is often delayed until after failure of other treatment modalities, resulting in potentially long delays between diagnosis and initiation of infliximab or adalimumab. We aim to determine if early treatment with anti-TNF agents reduces the rate of surgical resection and clinical secondary loss of response in CD patients. Methods:A retrospective cohort study was conducted evaluating CD outpatients who were primary responders to anti-TNF therapy, on a maintenance regimen with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first dose of anti-TNF therapy; early initiation was defined as starting anti-TNF therapy within 2 years of diagnosis. The primary outcome was occurrence of surgical resection or clinical secondary loss of response requiring dose escalation. Kaplan-Meier analysis was used to assess time to the primary outcomes. Results:One hundred ninety CD patients met inclusion criteria (100 infliximab, 90 adalimumab). Median follow-up duration was 154.4 weeks (inter quartile range, 106.4–227.8). Fifty-three patients (27.9%) had early initiation of anti-TNF therapy. Fewer patients in the early initiation group required surgery (5.7% versus 30.7%, P < 0.001) or experienced clinical secondary loss of response (45.3% versus 67.2%, P = 0.006). In Kaplan-Meier analysis, early initiation of anti-TNF therapy prolonged time to surgery (P = 0.001) and secondary loss of response (P = 0.006). Conclusions:In CD patients, early initiation of infliximab or adalimumab within the first 2 years of diagnosis reduces the rate of surgery and secondary loss of response requiring dose escalation.

Similar Clinical and Surgical Outcomes Achieved with Early Compared to Late Anti-TNF Induction in Mild-to-Moderate Ulcerative Colitis: A Retrospective Cohort Study

Background. Biologic agents targeting tumor necrosis factor alpha are effective in the management of ulcerative colitis (UC), but their use is often postponed until after failure of other treatment modalities. Objectives. We aim to determine if earlier treatment with infliximab or adalimumab alters clinical and surgical outcomes in UC patients. Methods. A retrospective cohort study was conducted evaluating UC outpatients treated with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first anti-TNF exposure; early initiation was defined as starting treatment within three years of diagnosis. Primary outcomes were colectomy, UC-related hospitalization, and clinical secondary loss of response. Kaplan-Meier analysis was used to assess time to the primary outcomes. Results. 115 patients were included (78 infliximab, 37 adalimumab). Median follow-up was 175.6 weeks (IQR 72.4–228.4 weeks). Fifty-seven (49.6%) patients received early anti-TNF therapy; median time to treatment in this group was 38.1 (23.3–91.0) weeks compared to 414.0 (254.0–561.3) weeks in the late initiator cohort (p < 0.0001). Patients treated with early anti-TNF therapy had more severe endoscopic disease at induction (mean Mayo endoscopy subscore 2.46 (SD ± 0.66) versus 1.86 (±0.67), p < 0.001) and trended towards increased risk of colectomy (17.5% versus 8.6%, p = 0.16) and UC-related hospitalization (43.9% versus 27.6%, p = 0.07). In multivariate regression analysis, early anti-TNF induction was not associated with colectomy (HR 2.02 [95% CI: 0.57–7.20]), hospitalization (HR 1.66 [0.84–3.30]), or secondary loss of response (HR 0.86 [0.52–1.42]). Conclusions. Anti-TNF therapy is initiated earlier in patients with severe UC but earlier treatment does not prevent hospitalization, colectomy, or secondary loss of response.

Real-Life Treatment Paradigms Show Adalimumab Is Cost-Effective for the Management of Ulcerative Colitis

Background. Adalimumab is effective for the maintenance of remission in patients with moderate-to-severe ulcerative colitis (UC). Currently, biologic therapies are used in cases where patients fail conventional medical therapies. If biologic therapies are not available, patients often choose to remain in an unwell state rather than undergo colectomy. Objective. The aim of the study was to evaluate the cost-effectiveness of adalimumab in patients with UC where adalimumab was readily available compared to not available. Methods. A previously validated Markov model was used to simulate disease progression of patients with UC who are corticosteroid-dependent and/or did not respond to thiopurine therapy. Utility scores and transition probabilities between health states were determined by using data from randomized controlled trials and real-life observational studies. Costs were obtained from the Ontario Case Costing Initiative and the Alberta Health Schedule of Medical Benefits. Results. The incremental cost-effectiveness ratios for readily available adalimumab treatment of UC were

A104 COST-EFFECTIVENESS OF INFLIXIMAB BIOSIMILAR FOR THE MANAGEMENT OF CROHN’S DISEASE

40,000 and

Cost-Effectiveness of Infliximab's Biosimilar CT-P13 Compared to Innovator Infliximab for the Management of Crohn's Disease

59,000 per quality-adjusted life year, compared with ongoing medical therapy in an unwell state, at 5-year and 10-year treatment time horizons, respectively. Conclusion. Considering real-life patient preferences to avoid colectomy, adalimumab is cost-effective according to a willingness-to-pay threshold of

A103 EARLY INITIATION OF ANTI-TNF THERAPY IS COST-SAVING COMPARED TO LATE INITIATION FOR PATIENTS WITH CROHN’S DISEASE

80,000 for treatment of UC.

A74 COST-EFFECTIVENESS OF VEDOLIZUMAB COMPARED TO INFLIXIMAB FOR THE MANAGEMENT OF MODERATE-TO-SEVERE ULCERATIVE COLITIS

Background: Infliximab is an anti-TNF therapy with proven efficacy for the induction and maintenance of remission in patients with Crohn’s disease (CD). An infliximab biosimilar, CTP13 (marketed as Inflectra), has recently been introduced that could potentially result in large cost-savings for this patient population. However, the molecular complexity and sensitivity to changes in manufacturing of biologic agents makes it difficult to verify the similarity of biosimilars to their respective innovator biologics. Due to these challenges, it is important to assess the effect of biosimilars on patient outcomes while considering the cost-savings associated with these therapies. Aims: The aim of this study was to provide an economic analysis comparing the costeffectiveness of infliximab (Remicade) to its biosimilar (Inflectra) for the management of CD. Methods: A Markov model was constructed to simulate the progression of patients with CD after initiating either infliximab or its biosimilar, Inflectra. Based on this model, we calculated the cost and effectiveness of each treatment strategy over a 5-year time horizon. Transition probabilities were obtained from a literature search, and loss of response rates were obtained from published centre data and observational studies. The cost of health states were accessed using the CIHI patient cost estimator, and the cost of infliximab (Remicade and Inflectra) was obtained from the Alberta Health and Wellness Drug Benefit List. Utility values were obtained from a literature search, and the Standard Gamble approach was used. Deterministic and probabilistic sensitivity analysis was executed to characterize uncertainty. Results: Over a 5-year period, infliximab therapy costs

A73 COST-EFFECTIVENESS OF INFLIXIMAB BIOSIMILAR COMPARED TO ORIGINATOR INFLIXIMAB FOR THE MANAGEMENT OF CROHN’S DISEASE

167,388 and yielded 3.91 quality-