Real-world biologic treatment and associated cost in patients with inflammatory bowel disease

Brandes, Alina; Groth, Antje; Gottschalk, Frank; Wilke, Thomas; Ratsch, Boris A.; Orzechowski, Hans‐Dieter; Fuchs, Andreas; Deiters, Barthold; Bokemeyer, Bernd

doi:10.1055/a-0903-2938

Cited by 18 publications

(16 citation statements)

References 16 publications

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“…Interestingly, we discovered an increase in the frequency of β7 + CD4 memory T cells in blood, but a decrease of these cells in RB. These findings suggest that the administration of anti-α4β7 mAb reduced the trafficking of α4β7 hi T cells to the gut, confirming the mode of action, prevention of trafficking of activated T cells to the gut, of vedoluzimab as adjunctive therapy in inflammatory bowel disease and Crohn disease (IBD/CD) (29)(30)(31)(32)(33)(34). As such, a similar strategy is of interest in the context of HIV infection, where CD4 T cells that express CCR5 and α4β7 are the preferred target for HIV infection in the gut, a major site for early HIV infection and replication (2,(35)(36)(37).…”

Section: Discussionmentioning

confidence: 61%

Safety and Immunological Evaluation of Interleukin-21 Plus Anti-α4β7 mAb Combination Therapy in Rhesus Macaques

et al. 2020

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Human immunodeficiency virus (HIV) and simian immunodeficiency virus (SIV) infections compromise gut immunological barriers, inducing high levels of inflammation and a severe depletion of intestinal CD4 + T cells. Expression of α4β7 integrin promotes homing of activated T cells to intestinal sites where they become preferentially infected; blockade of α4β7 with an anti-α4β7 monoclonal antibody (mAb) prior to infection has been reported to reduce gut SIV viremia in rhesus macaques (RMs). Interleukin-21 (IL-21) administration in antiretroviral therapy-treated, SIV-infected RMs reduces gut inflammation and improves gut integrity. We therefore hypothesized that the combination of IL-21 and anti-α4β7 mAb therapies could synergize to reduce inflammation and HIV persistence. We co-administered two intravenous doses of rhesus anti-α4β7 mAb (50 mg/kg) combined with seven weekly subcutaneous infusions of IL-21-IgFc (100 µg/kg) in four healthy, SIV-uninfected RMs to evaluate the safety and immunological profiles of this intervention in blood and gut. Co-administration of IL-21 and anti-α4β7 mAb showed no toxicity at the given dosages as assessed by multiple hematological and chemical parameters and did not alter the bioavailability of the therapeutics or result in the generation of antibodies against the anti-α4β7 mAb or IL-21-IgFc. Upon treatment, the frequency of CD4 memory T cells expressing β7 increased in blood and decreased in gut, consistent with an inhibition of activated CD4 T-cell homing to the gut. Furthermore, the frequency of T cells expressing proliferation and immune activation markers decreased in blood and, more profoundly, in gut. The combined IL-21 plus anti-α4β7 mAb therapy is well-tolerated in SIV-uninfected RMs and reduces the gut homing of α4β7 + CD4 T cells as well as the levels of gut immune activation.

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Section: Discussionmentioning

confidence: 61%

Safety and Immunological Evaluation of Interleukin-21 Plus Anti-α4β7 mAb Combination Therapy in Rhesus Macaques

et al. 2020

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“…From 2010 to 2018, sales volume for infliximab and adalimumab increased over two-fold, and 1.8-fold for etanercept (see Figure 1 ). The rise in the sales volume of TNFα inhibitors has been attributed to several factors (e.g., the lower threshold at which treatment with biologics is initiated, changes in the dosing regimen) [ 24 , 25 ]. In the case of infliximab and etanercept, the data in this study showed that year-over-year increases (%) in use occurred shortly after biosimilar entry (13.4% increase for infliximab and 13.7% increase for etanercept).…”

Section: Resultsmentioning

confidence: 99%

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

et al. 2020

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Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region. We examine regional market dynamics of tumor necrosis factor alpha (TNFα) inhibitor originators and biosimilars in Germany and studied the influence of biosimilar policies on these dynamics. This study is based on: (1) a literature review in which German biosimilar policies are identified, (2) the analysis of dispensing data (2010–2018) for the class of TNFα inhibitors, and (3) ten semi-structured interviews investigating prescribers’ and insurers’ views on factors potentially influencing biosimilar uptake. The analysis of biosimilar market shares of infliximab and etanercept revealed wide variations across the 17 German Regional Associations of Statutory Health Insurance Accredited Physicians (PA regions). Quantitative analyses indicated that biosimilar market shares for infliximab and etanercept were significantly lower in former East Germany when compared to former West Germany regions. Through qualitative interview analyses, this study showed that the use of infliximab and etanercept biosimilars across Germany is primarily influenced by (1) the regional-level implementation of biosimilar quotas and the presence of monitoring/sanctioning mechanisms to ensure adherence to these quotas, (2) the different insurer-manufacturer discount contracts, and (3) gainsharing arrangements established at the insurer-prescriber level.

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“…In consequence, patients with mild disease who did not require treatment with IS or systemic corticosteroids (CS) have been excluded. Further, all patients who received a biologic during the index or follow-up period were excluded, as treatment with biologics was already analyzed in a recent study based on the same dataset [17]. Patients with prescriptions of calcineurin inhibitors were also excluded as this is a last-line treatment after biologics in most cases.…”

Section: Methodsmentioning

confidence: 99%

“…Several previous studies addressed the real-world treatment of moderate-to-severe IBD patients receiving biologic therapies [12][13][14][15][16]. However, in Germany as in most other western European countries, the majority of IBD patients are treated with conventional non-biologic therapies [17]. Treatment with non-biologic drugs has not been studied in detail over the recent years.…”

Section: Introductionmentioning

confidence: 99%

Indicators of active disease and steroid dependency in patients with inflammatory bowel diseases not treated with biologics in a German real-world-setting

Bokemeyer

Ghiani

Fuchs³

et al. 2020

Int J Colorectal Dis

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Background and aims While a minority of inflammatory bowel disease (IBD) patients receives biologics in Germany, little is known about therapeutic needs of patients receiving non-biologic therapies. This study aimed to identify indicators of active disease/steroid dependency in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC) treated with conventional therapies and to describe health care resource use (HCRU)/cost. Methods CD/UC patients treated with immunosuppressants (IS) and/or systemic or locally acting oral corticosteroids (CS) were identified in German claims data (2013-2017) and followed for 12 months post-therapy start. Indicators of active disease/steroid dependency during follow-up period were (i) ≥ 2 prescriptions of CS (sensitivity ≥ 4) or (ii) ≥ 1 IBD-related surgery or (iii) > 7 days IBD-related hospitalization(s). Results Of 9871 included IBD patients (5170 CD, 4701 UC), 25.7%/19.9% (CD/UC) received ≥ 2 prescriptions of CS (sensitivity, 17.4%/15.7%) (i), 3.2% experienced IBD-related surgeries (ii), and 2.5% > 7 days of hospitalizations (iii). Altogether, 44.4% had indicators of active disease/steroid dependency (sensitivity, 23.9%). Among patients with active disease/steroid dependency, 78.0% received CS monotherapy at baseline. Of these, 89.6% received a CS monotherapy in the follow-up period, too. Proportionally, fewer patients with CS monotherapy (57.4%) than IS therapy (91.0%) visited a specialist. HCRU/cost per patient year was significantly higher in patients with than without active disease/steroid dependency. The manuscript, including related data, figures, and tables has not been previously published and the manuscript is not under consideration elsewhere.

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Real-world biologic treatment and associated cost in patients with inflammatory bowel disease

Cited by 18 publications

References 16 publications

Safety and Immunological Evaluation of Interleukin-21 Plus Anti-α4β7 mAb Combination Therapy in Rhesus Macaques

Safety and Immunological Evaluation of Interleukin-21 Plus Anti-α4β7 mAb Combination Therapy in Rhesus Macaques

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Indicators of active disease and steroid dependency in patients with inflammatory bowel diseases not treated with biologics in a German real-world-setting

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