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. 2023 May 8;38(1):116.
doi: 10.1007/s00384-023-04397-7.

Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany

Bernd Bokemeyer  1 , Nils Picker  2 , Daniel Kromer  2 , Ludger Rosin  3 , Haridarshan Patel  4
Affiliations

Rates of clinical remission and inadequate response to advanced therapies among patients with ulcerative colitis in Germany

Bernd Bokemeyer et al. Int J Colorectal Dis. .

Abstract

Purpose: Many patients treated for ulcerative colitis (UC) do not achieve clinical remission. This real-world study assessed clinical remission and inadequate response rates among patients with UC in Germany treated with advanced therapies.

Methods: This retrospective chart review included patients with UC newly initiating advanced (index) therapy (anti-TNFα agents, vedolizumab, tofacitinib) from January 2017-September 2019 (index date). Included patients had data for ≥ 12 months before (baseline period) and after the index date (follow-up period). Remission was defined as a partial Mayo score ≤ 1. Indicators of inadequate response were: index therapy discontinuation; therapy adjustments (index therapy dose escalation; augmentation with non-advanced therapies; corticosteroid [CS] use during maintenance therapy); CS dependency (use for ≥ 12 weeks); and UC-related hospitalisation, surgery or emergency department visit. Time to first remission and inadequate response were analyzed using Kaplan-Meier analyses.

Results: Among 149 patients with UC (median age: 40 years), 96 (64.4%) were biologic-naïve and 42 (28.2%) received CS at the index date. Within 12 months, 52 patients (47.2%) were in remission; of these, 13 patients (25.0%) received ≥ 1 therapy adjustment. At 12 months, 55 patients (37.6%) had ≥ 1 indicator of an inadequate response. Median time to remission was longer among biologic-experienced vs biologic-naïve patients (24 vs 7 months; p = 0.012).

Conclusion: Over half of the patients were not in clinical remission after 12 months and more than one-third experienced inadequate response. One-quarter of patients in remission required therapy adjustments. Patients with UC require therapies that are more effective than those currently available to achieve better treatment outcomes.

Keywords: Advanced therapy; Inadequate response; Real-world treatment; Ulcerative colitis.

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Conflict of interest statement

Bernd Bokemeyer received consultancy fees and speaking fees from AbbVie, Arena, Biogen, Celgene, Celltrion, Falk, Ferring, Galapagos Biopharma Deutschland GmbH, Janssen, MSD, Pfizer and Takeda. Nils Picker and Daniel Kromer are employees of Ingress-Health; the work of Ingress-Health in this study was funded by Galapagos NV. Ludger Rosin is an employee of Galapagos Biopharma Deutschland GmbH. Haridarshan Patel is a former employee of Galapagos NV.

Figures

Fig. 1
Fig. 1
Time to first clinical remission among patients with UC treated with advanced therapy. Patients without a partial Mayo score at baseline (n = 12) were excluded UC, ulcerative colitis
Fig. 2
Fig. 2
Time to first clinical remission among patients with UC treated with advanced therapy by (a) previous biologic usea and (b) CS use at index dateb aPatients without a partial Mayo score at baseline (n = 12) were excluded. Patients with incomplete medication history information were also excluded (n = 2) bPatients without a partial Mayo score at baseline (n = 12) were excluded Bio, biologic; CS, corticosteroid; UC, ulcerative colitis
Fig. 3
Fig. 3
Proportion of patients with inadequate response to index therapy by indicator measured at 3, 6, 12 and 24 months CS, corticosteroid; ED, emergency department; UC, ulcerative colitis
Fig. 4
Fig. 4
Time to any indicator of inadequate response among patients with UC treated with advanced therapy by (a) CS use at index date, (b) remission status within the first 12 months of follow-upa and (c) previous biologic use aPatients without a partial Mayo score at baseline (n = 12) were excluded Bio, biologic; CS, corticosteroid; UC, ulcerative colitis
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References

    1. Kucharzik T, Dignass AU, Atreya R, et al. Updated S3-Guideline ulcerative colitis. German society for digestive and metabolic diseases (DGVS) Z für Gastroenterol. 2019;57:162–241. doi: 10.1055/A-0824-0861. - DOI - PubMed
    1. Alulis S, Vadstrup K, Olsen J, et al. The cost burden of Crohn’s disease and ulcerative colitis depending on biologic treatment status – a Danish register-based study. BMC Health Serv Res. 2021;21:836. doi: 10.1186/s12913-021-06816-3. - DOI - PMC - PubMed
    1. Constantin J, Atanasov P, Wirth D, Borsi A. Indirect costs associated with ulcerative colitis: a systematic literature review of real-world data. BMC Gastroenterol. 2019;19:179. doi: 10.1186/s12876-019-1095-9. - DOI - PMC - PubMed
    1. Pöllinger B, Schmidt W, Seiffert A, Imhoff H, Emmert M. Costs of dose escalation among ulcerative colitis patients treated with adalimumab in Germany. Eur J Health Econ. 2019;20:195–203. doi: 10.1007/s10198-017-0953-z. - DOI - PubMed
    1. Prenzler A, Bokemeyer B, Von DSJM, Mittendorf T. Health care costs and their predictors of inflammatory bowel diseases in Germany. Eur J Health Econ. 2011;12:273–283. doi: 10.1007/s10198-010-0281-z. - DOI - PubMed

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