Living with ulcerative colitis in Germany: a retrospective analysis of dose escalation, concomitant treatment use and healthcare costs

Dignaß, Axel; Waller, John; Cappelleri, Joseph C.; Modesto, Irene; Kisser, Agnes; Dietz, Lena; DiBonaventura, Marco; Wood, Robert; May, Melanie; Libutzki, Berit; Bargo, Danielle

doi:10.1080/13696998.2019.1707210

Cited by 12 publications

(37 citation statements)

References 47 publications

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“…Approximately half of patients used an IM with a TNFi in follow-up, slightly higher than the 41% of patients who used an IM with biologic therapy in an equivalent study of German patients [28]. Steroid use with a TNFi was substantially lower (<5%) than was observed among German patients when accounting for steroid tapering (25%) [28].…”

Section: Discussion/conclusionmentioning

confidence: 82%

“…Data collected during the 2 years prior to the index date (baseline period) and the 2 years after the index date (follow-up period) were evaluated. This study is one of two studies conducted to describe real-world outcomes in patients with UC, and the other to describe health-care resource utilization (HCRU) and treatment patterns among patients with UC in Germany [28] (shown in Fig. 1).…”

Section: Methodsmentioning

confidence: 99%

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Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use

et al. 2021

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Objective: The aim of the study was to improve understanding of adherence and persistence to biologics, and their association with health-care resource utilization (HCRU), in Japanese patients with moderate to severe ulcerative colitis (UC). Methods: Data were from Medical Data Vision, a secondary care administrative database. A retrospective, longitudinal cohort analysis was conducted of data from UC patients initiating biologic therapy between August 2013 and July 2016. Data collected for 2 years prior (baseline) and 2 years after (follow-up) the index date were evaluated. Patients completing biologic induction were identified, and adherence/persistence to biologic therapy calculated. HCRU, steroid, and immunosuppressant use during baseline and follow-up were assessed. Biologic switching during the follow-up was evaluated. Descriptive statistics (e.g., means and proportions) were obtained and inferential analyses (from Student’s t tests, Fisher’s exact tests, χ2 tests, the Cox proportional hazard model, and negative binomial regression) were performed. Results: The analysis included 649 patients (adalimumab: 265; infliximab: 384). Biologic induction was completed by 80% of patients. Adherence to adalimumab was higher than that to infliximab (p < 0.001). Persistence at 6, 12, 18, and 24 months was higher with infliximab than with adalimumab (p < 0.05). Overall, gastroenterology outpatient visits increased, and hospitalization frequency and duration decreased, from baseline to follow-up. UC-related hospitalizations were fewer and shorter, and endoscopies fewer, in persistent than in nonpersistent patients, although persistent patients made more outpatient visits than nonpersistent patients. Hospitalization duration was lower in persistent than nonpersistent patients. Approximately 50% of patients received an immunosuppressant during biologic therapy; 5% received a concomitant steroid during biologic therapy. Overall, 17% and 3% of patients, respectively, received 2nd line and 3rd line biologics. Conclusions: Poor biologic persistence was associated with increased non-medication-associated HCRU. Effective treatments with high persistence levels and limited associated HCRU are needed in UC.

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Section: Discussion/conclusionmentioning

confidence: 82%

Section: Methodsmentioning

confidence: 99%

Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use

et al. 2021

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“…There were 9 reports of dose escalation done to address LOR, 31 , 44 , 46 , 63 , 66–68 , 75 , 76 whereas the remaining 39 dose escalations were done for any reason ( Figure 2 ). 22–29 , 32 , 34 , 35 , 37 , 38 , 40–42 , 45 , 47–52 , 55 , 57–62 , 64 , 65 , 69 , 71 , 72 , 74 The average rate of escalation by dose increase varied greatly, ranging from 80% to 340% relative to the starting dose ( Supplementary Table 5 ). 26 , 29 , 31 , 35 , 36 , 38 , 40 , 46 , 49 , 52 , 57 , 59 , 61–63 , 65–69 , 75 In studies with follow-up times of ≤12 months, the rate of dose escalation was 11.5–44%, whereas in studies with follow-up times of >12-≤24 months and >24 months, the rate of dose escalation was 8.4–73.5% and 4.9–54.0%, respectively ( Supplementary Table 4 ).…”

Section: Resultsmentioning

confidence: 99%

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Singh¹,

Wilson²,

Tencer³

et al. 2023

CEOR

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Background Currently approved biologic therapies for moderate-to-severe ulcerative colitis have well-established efficacy. However, many patients fail to respond or lose response, leading to dose escalation or treatment switching. Objective We sought to identify real-world evidence on dose escalation and treatment switching and associated clinical and economic outcomes among adults with ulcerative colitis treated with infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, or tofacitinib. Methods We conducted a systematic search of Embase, MEDLINE (up to 26 August 2020), and conference proceedings (2017−2020) for studies in adults with ulcerative colitis to assess clinical response and remission, colectomy, adverse events, and economic outcomes related to dose escalation and treatment switching. Results In 56 studies, dose escalation and treatment switching involving infliximab and/or adalimumab were most frequently investigated. Rates of clinical response after dose escalation were 20–95% (1.8–36 months), clinical remission rates were 10–94% (1.8–36 months), colectomy rates were 0–33% (12–38 months), and adverse event rates were 0–18%. Treatment switching rates in 21 studies were 4–70% over 3–62 months, with switch due to loss of response rates of 4–35% over 12–62 months (7 studies). Up to 35% of patients underwent colectomy 12−120 weeks after switching, and 13–38% experienced adverse events. Data relating to economic outcomes were limited to tumor necrosis factor inhibitors, but demonstrated increased direct costs associated with both dose escalation and treatment switching. Conclusion Dose escalation and treatment switching are common with existing therapies. However, clinical response and remission rates vary, and a proportion of patients fail to achieve optimal clinical and economic outcomes. This highlights the need for more efficacious and durable treatments for patients with moderate-to-severe ulcerative colitis.

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“…Five systematic reviews were identified, 6 – 10 and 81 case series selected and listed on Table 2 11 …”

Section: Results – Dose Intensificationmentioning

confidence: 99%

Optimizing biologic therapy in inflammatory bowel disease: a Delphi consensus in the United Arab Emirates

Annese¹,

Nathwani

Alkhatry

et al. 2021

Therap Adv Gastroenterol

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Background: Inflammatory bowel diseases (IBD) are chronic, relapsing-remitting inflammatory conditions with a substantial negative impact on health-related quality of life and work productivity. Treatment of IBD has been revolutionized by the advent of biologic therapies, initially with anti-TNF agents and more recently with multiple alternatives targets, and yet more under development. Objectives: Approximatively one third of patients do not respond to biologic therapy and more importantly a significant proportion experiences partial response or loss of response during treatment. The latter are common clinical situations and paradoxically are not addressed in the commercial drug labels and available guidelines. There is therefore a clinical need for physicians to understand when and how eventually to optimize the biologic therapy. Design: This consensus using a Delphi methodology was promoted and supported by the Emirates Society of Gastroenterology and Hepatology to close this gap. Data Sources and Methods: Following an extensive systematic review of over 60,000 studies, 81 studies with dose escalation and five addressing drug monitoring were selected and in addition five systematic reviews and three guidelines. Results and Conclusion: after three rounds of voting 18 statements were selected with agreement ranging from of 80% to 100%

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Living with ulcerative colitis in Germany: a retrospective analysis of dose escalation, concomitant treatment use and healthcare costs

Cited by 12 publications

References 47 publications

Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use

Living with Ulcerative Colitis in Japan: Biologic Persistence and Health-Care Resource Use

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Optimizing biologic therapy in inflammatory bowel disease: a Delphi consensus in the United Arab Emirates

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