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Advances in Therapy

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Open Access 01-09-2019 | Infliximab | Original Research

Retrospective Claims Analysis Indirectly Comparing Medication Adherence and Persistence Between Intravenous Biologics and Oral Small-Molecule Therapies in Inflammatory Bowel Diseases

Authors: Kellyn Moran, Kyle Null, Zhongwen Huang, Trevor Lissoos, Sunanda Kane

Published in: Advances in Therapy | Issue 9/2019

Abstract

Introduction

Patients’ adherence to and persistence on treatment for inflammatory bowel disease (IBD) can vary, depending on type and distribution of disease and treatment modality. We aim to identify differences in adherence and persistence with treatments with different administration routes (intravenous vs oral) in IBD.

Methods

A retrospective cohort analysis of a claims database of adult patients diagnosed with IBD or rheumatoid arthritis (RA) who began treatment with vedolizumab, tofacitinib, or infliximab from January 2015 through December 2015. Adherence evaluated by proportion of days covered (PDC) and cumulative days with gaps at least 20% beyond expected interval (CG20) using multivariable generalized linear equation models. Persistence assessed as time to treatment discontinuation over 12 months of follow-up using Kaplan–Meier estimates and Cox proportional hazards models; proportion of persistent patients determined via multivariable logistic regression. Indirect comparisons across disease states adjusted using infliximab data.

Results

After indirect adjustment by disease, mean PDC difference was significantly higher (difference of 4.7%; P = 0.0376) and mean CG20 was lower (difference of 15 days; P = 0.0646) but not statistically significant in vedolizumab/IBD than tofacitinib/RA.

Conclusion

We describe a novel adjustment method for interdisease treatment differences using infliximab treatment patterns to bridge differences between IBD and RA. After adjustment, adherence was higher with infusions than oral medications, which may affect outcomes. Indirect comparisons between vedolizumab and tofacitinib are not generalizable and should be confirmed in tofacitinib-treated IBD patients.

Funding

Takeda Pharmaceuticals U.S.A., Inc.

Available only for authorised users

Herman ML, Kane SV. Treatment nonadherence in inflammatory bowel disease: identification, scope, and management strategies. Inflamm Bowel Dis. 2015;21(12):2979–84. https://doi.org/10.1097/MIB.0000000000000581.CrossRefPubMed

Li P, Blum MA, Von Feldt J, Hennessy S, Doshi JA. Adherence, discontinuation, and switching of biologic therapies in Medicaid enrollees with rheumatoid arthritis. Value Health. 2010;13(6):805–12. https://doi.org/10.1111/j.1524-4733.2010.00764.x.CrossRefPubMed

Morrison VL, Holmes EA, Parveen S, et al. Predictors of self-reported adherence to antihypertensive medicines: a multinational, cross-sectional survey. Value Health. 2015;18(2):206–16. https://doi.org/10.1016/j.jval.2014.12.013.CrossRefPubMed

Rannanheimo PK, Tiittanen P, Hartikainen J, et al. Impact of statin adherence on cardiovascular morbidity and all-cause mortality in the primary prevention of cardiovascular disease: a population-based cohort study in Finland. Value Health. 2015;18(6):896–905. https://doi.org/10.1016/j.jval.2015.06.002.CrossRefPubMed

Lakatos PL. Prevalence, predictors, and clinical consequences of medical adherence in IBD: how to improve it? World J Gastroenterol. 2009;15(34):4234–9.CrossRefPubMedPubMedCentral

Lopez A, Billioud V, Peyrin-Biroulet C, Peyrin-Biroulet L. Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis. 2013;19(7):1528–33. https://doi.org/10.1097/MIB.0b013e31828132cb.CrossRefPubMed

Panaccione R, Rutgeerts P, Sandborn WJ, Feagan B, Schreiber S, Ghosh S. Review article: treatment algorithms to maximize remission and minimize corticosteroid dependence in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2008;28(6):674–88. https://doi.org/10.1111/j.1365-2036.2008.03753.x.CrossRefPubMed

Jackson CA, Clatworthy J, Robinson A, Horne R. Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol. 2010;105(3):525–39. https://doi.org/10.1038/ajg.2009.685.CrossRefPubMed

Bressler B, Haraoui B, Keystone E, Sette A. Optimizing use of tumor necrosis factor inhibitors in the management of immune-mediated inflammatory diseases. J Rheumatol Suppl. 2010;85:40–52. https://doi.org/10.3899/jrheum.091464.CrossRefPubMed

10.

Vangeli E, Bakhshi S, Baker A, et al. A systematic review of factors associated with non-adherence to treatment for immune-mediated inflammatory diseases. Adv Ther. 2015;32(11):983–1028. https://doi.org/10.1007/s12325-015-0256-7.CrossRefPubMedPubMedCentral

11.

Seal BS, Anderson S, Shermock KM. Factors associated with adherence rates for oral and intravenous anticancer therapy in commercially insured patients with metastatic colon cancer. J Manag Care Spec Pharm. 2016;22(3):227–35. https://doi.org/10.18553/jmcp.2016.22.3.227.CrossRefPubMed

12.

Entyvio^® (vedolizumab) [prescribing information]. Deerfield: Takeda Pharmaceuticals America; 2014.

13.

Xeljanz^® (tofacitinib) [prescribing information]. New York: Pfizer; 2017.

14.

US Food and Drug Administration. FDA approves new treatment for moderately to severely active ulcerative colitis [press release]. Silver Spring: US Food and Drug Administration; 2018. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-moderately-severely-active-ulcerative-colitis. Accessed 1 May 2019.

15.

Remicade^® (infliximab) [prescribing information]. Horsham: Janssen Biotech, Pfizer; 2013.

16.

Alten R, Kruger K, Rellecke J, et al. Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. Patient Prefer Adherence. 2016;10:2217–28.CrossRefPubMedPubMedCentral

17.

Eek D, Krohe M, Mazar I, et al. Patient-reported preferences for oral versus intravenous administration for the treatment of cancer: a review of the literature. Patient Prefer Adherence. 2016;10:1609–21. https://doi.org/10.2147/PPA.S106629.CrossRefPubMedPubMedCentral

18.

Wentworth BJ, Buerlein RCD, Tuskey AG, Overby MA, Smolkin ME, Behm BW. Nonadherence to biologic therapies in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(9):2053–61. https://doi.org/10.1093/ibd/izy102.CrossRefPubMed

19.

Howe A, Eyck LT, Dufour R, Shah N, Harrison DJ. Treatment patterns and annual drug costs of biologic therapies across indications from the Humana commercial database. J Manag Care Spec Pharm. 2014;20(12):1236–44.PubMed

20.

Degli Esposti L, Sangiorgi D, Perrone V, et al. Adherence and resource use among patients treated with biologic drugs: findings from BEETLE study. Clinicoecon Outcomes Res. 2014;6:401–7. https://doi.org/10.2147/CEOR.S66338.CrossRefPubMedPubMedCentral

21.

Srivastava K, Arora A, Kataria A, Cappelleri JC, Sadosky A, Peterson AM. Impact of reducing dosing frequency on adherence to oral therapies: a literature review and meta-analysis. Patient Prefer Adherence. 2013;7:419–34. https://doi.org/10.2147/PPA.S44646.CrossRefPubMedPubMedCentral

22.

Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711–21. https://doi.org/10.1056/NEJMoa1215739.CrossRefPubMed

23.

Ylisaukko-Oja T, Aaltonen J, Nuutinen H, et al. High treatment persistence rate and significant endoscopic healing among real-life patients treated with vedolizumab: a Finnish Nationwide Inflammatory Bowel Disease Cohort Study (FINVEDO). Scand J Gastroenterol. 2018;53(2):158–67. https://doi.org/10.1080/00365521.2017.1416160.CrossRefPubMed

24.

Allegretti JR, Barnes EL, Stevens B, et al. Predictors of clinical response and remission at 1 year among a multicenter cohort of patients with inflammatory bowel disease treated with vedolizumab. Dig Dis Sci. 2017;62(6):1590–6. https://doi.org/10.1007/s10620-017-4549-3.CrossRefPubMedPubMedCentral

25.

Stallmach A, Langbein C, Atreya R, et al. Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease: a prospective multicenter observational study. Aliment Pharmacol Ther. 2016;44(11–12):1199–212. https://doi.org/10.1111/apt.13813.CrossRefPubMed

26.

Vivio EE, Kanuri N, Gilbertsen JJ, et al. Vedolizumab effectiveness and safety over the first year of use in an IBD clinical practice. J Crohns Colitis. 2016;10(4):402–9. https://doi.org/10.1093/ecco-jcc/jjv226.CrossRefPubMed

27.

Eriksson C, Marsal J, Bergemalm D, et al. Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). Scand J Gastroenterol. 2017;52(6–7):722–9. https://doi.org/10.1080/00365521.2017.1304987.CrossRefPubMed

28.

Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723–36. https://doi.org/10.1056/nejmoa1606910.CrossRefPubMed

29.

US Food and Drug Administration. Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. https://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr. Published February 25, 2019. Accessed 1 May 2019.

Title: Retrospective Claims Analysis Indirectly Comparing Medication Adherence and Persistence Between Intravenous Biologics and Oral Small-Molecule Therapies in Inflammatory Bowel Diseases
Authors: Kellyn Moran
Kyle Null
Zhongwen Huang
Trevor Lissoos
Sunanda Kane
Publication date: 01-09-2019
Publisher: Springer Healthcare
Keywords: Infliximab
Ulcerative Colitis
Crohn's Disease
Chronic Inflammatory Bowel Disease
Rheumatoid Arthritis
Published in: Advances in Therapy / Issue 9/2019
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-019-01037-x

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Retrospective Claims Analysis Indirectly Comparing Medication Adherence and Persistence Between Intravenous Biologics and Oral Small-Molecule Therapies in Inflammatory Bowel Diseases

Abstract

Introduction

Methods

Results

Conclusion

Funding

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Abstract

Introduction

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Results

Conclusion

Funding

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