Costs of dose escalation among ulcerative colitis patients treated with adalimumab in Germany

Pöllinger, Bernadette; Schmidt, Wolfgang; Seiffert, Anna; Imhoff, Heidi; Emmert, Martin

doi:10.1007/s10198-017-0953-z

Cited by 11 publications

(15 citation statements)

References 24 publications

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“…Dose escalations of >50% were reported for some patients receiving each of the four indexed biologics, with 50% or more of patients receiving adalimumab, infliximab and vedolizumab, and 19% of patients receiving golimumab, having this level of increase. The extent of dose escalation in patients receiving adalimumab seen in the current analysis, with 74% of patients having a dose increase of >50% within 2 years of initiation, exceeded that seen in a previous analysis of German prescription data, in which dose escalations of >50% were observed within 12 months in 45% of patients receiving adalimumab 29 , and in a UK study, in which 55% of patients had an increase in adalimumab dose of !50% during an undefined period 38 . In a retrospective analysis of US claims data for patients receiving adalimumab, infliximab, golimumab, certolizumab pegol, or natalizumab, >50% dose escalation within 2 years of initiation of treatment was reported in 40% of patients 39 .…”

Section: Discussioncontrasting

confidence: 72%

“…The high cost of biologic therapy is expected to be offset to some degree by reductions in indirect costs, such as those associated with impaired productivity and sick leave; while sick leave was assessed, it was included in an alternative publication 43 . Dose escalations in biologics being used to treat UC have been shown to be associated with increases in drug costs in both an analysis of German prescription data 29 and a Spanish observational study 44 , while an analysis of US insurance claims data has shown treatment switching, dose escalation and the need for combination therapy all result in increases in HCRU and costs 26 .…”

Section: Discussionmentioning

confidence: 99%

“…Despite the importance of effective long-term treatment in UC, medication changes observed in substantial proportions of patients are suggestive of suboptimal treatment response. In one US study of patients receiving 5-ASA, steroids, immunosuppressants or biologics as monotherapy, treatment changes (including discontinuation, switching, or dose escalation) were reported in 80% of patients within 12 months of initiating therapy 26 , and a dose increase of >50% was observed in almost half of patients receiving adalimumab in a retrospective analysis of German prescription data 29 .…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Dignaß

Waller

Cappelleri

et al. 2020

Journal of Medical Economics

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Aims: To investigate treatment of moderate-to-severe ulcerative colitis (UC) using real-world German health insurance claims data. Materials and methods: A retrospective, longitudinal cohort study was conducted from a German statutory health insurance database for adult patients with UC indexed on biologic therapy initiation (2013-2015). Anonymized data were evaluated for 12 months prior to (baseline) through 24 months after (follow-up) indexing. Biologic dose escalations, steroid and immunosuppressant use, healthcare resource utilization (HCRU) and direct healthcare costs were evaluated, with significant differences assessed across and between index biologics. Descriptive statistics, chi-square or Fisher's exact tests, and analysis of variance were performed. Results: The analysis included 304 patients (adalimumab, n ¼ 125; golimumab, n ¼ 47; infliximab, n ¼ 114; vedolizumab, n ¼ 18). Demographic and clinical characteristics were similar across biologics. Dose escalations occurred in 58% of patients (73% of patients receiving adalimumab), with 41% receiving subsequent de-escalation. Steroids were used during follow-up by 74% of patients; 25% received steroids >14 weeks after indexing. Overall, 41% of patients received an immunosuppressant during follow-up. Steroid and immunosuppressant use were similar across biologics. Total direct healthcare costs were higher during follow-up than baseline and differed significantly across treatments (p < .05), with highest costs for golimumab. Biologic costs contributed to a major portion of follow-up costs. HCRU and costs for most resources were higher in the first 12-month follow-up period than baseline. All resource use except gastroenterology visits returned to, or below, baseline levels 13-24 months post-index date. Limitations: There was potential for inappropriate inclusion/exclusion due to miscoding. Patients may have received biologics >12 months prior to the index date. Biologic originators and biosimilars could not be differentiated. Conclusions: These data suggest that control with current biologics is suboptimal. Further treatment options that provide sustained steroid-free remission for this patient population without the need for dose escalations or concomitant therapies may be warranted.

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Section: Discussioncontrasting

confidence: 72%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Dignaß

Waller

Cappelleri

et al. 2020

Journal of Medical Economics

View full text Add to dashboard Cite

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“…Of the 48 studies reporting dose escalation, 20 reported dose increases only, 14 reported interval shortening, and 14 reported dose escalation via both methods ( Supplementary Table 4 ). 21–29 , 31 , 32 , 34–38 , 40–42 , 45–52 , 54 , 55 , 57–69 , 71 , 72 , 74–76 One study did not describe the method of dose optimization. 24 Follow-up times varied from ≤12 months in 11 studies to >12-≤24 months in 10 studies and >24 months in 8 studies; follow-up times were not reported for the remaining 19 studies.…”

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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“…Despite a lack of clear recommendations for de-escalation, several studies have reported dose de-escalation rates that varied between 27 and 60% [ 2 , 3 , 11 , 12 ]. However, few studies have assessed the success rate of dose de-escalation after previous dose escalation.…”

Section: Introductionmentioning

confidence: 99%

De-escalation of biological therapy in inflammatory bowel disease patients following prior dose escalation

Thomas

Smits

Groen

et al. 2022

European Journal of Gastroenterology &Amp; Hepatology

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Background Limited data are available on biological therapy de-escalation after prior escalation in inflammatory bowel disease (IBD) patients. This study aimed to assess the frequency and success rate of de-escalation of biological therapy in IBD patients after prior dose escalation and to evaluate which measures are used to guide de-escalation. Methods This multicentre retrospective cohort study enrolled IBD patients treated with infliximab (IFX), adalimumab (ADA) or vedolizumab (VEDO) in whom therapy was de-escalated after prior biological escalation. De-escalations were considered pharmacokinetic-driven if based on clinical symptoms combined with therapeutic or supratherapeutic trough levels, and disease activity-driven if based on faecal calprotectin less than or equal to 200 µg/g or resolution of perianal fistula drainage or closure or endoscopic remission. Successful de-escalation was defined as remaining on the same or lower biological dose for greater than or equal to 6 months after de-escalation without the need for corticosteroids. Results In total, 206 IFX users, 85 ADA users and 55 VEDO users underwent therapy escalation. Of these patients, 34 (17%) on IFX, 18 (21%) on ADA and 8 (15%) on VEDO underwent therapy de-escalation. De-escalation was successful in 88% of IFX patients, 89% of ADA and 100% of VEDO. The probability of remaining on the de-escalated regimen or further de-escalation after 1 year was 85% for IFX, 62% for ADA and 100% for VEDO. Disease activity-driven de-escalations were more often successful (97%) than pharmacokinetic-and no marker-driven de-escalations (76%); P = 0.017. Conclusion De-escalation after biological dose escalation was successful in the majority of carefully selected IBD patients. Objective assessment of remission increased the likelihood of successful de-escalation.

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Costs of dose escalation among ulcerative colitis patients treated with adalimumab in Germany

Cited by 11 publications

References 24 publications

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

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

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

De-escalation of biological therapy in inflammatory bowel disease patients following prior dose escalation

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