Decreasing Colectomy Rate for Ulcerative Colitis in the United States Between 2007 and 2016: A Time Trend Analysis

Edward L Barnes, Yue Jiang, Michael D Kappelman, Millie D Long, Robert S Sandler, Alan C Kinlaw, Hans H Herfarth, Edward L Barnes, Yue Jiang, Michael D Kappelman, Millie D Long, Robert S Sandler, Alan C Kinlaw, Hans H Herfarth

Abstract

Background: Improved treatment approaches for ulcerative colitis (UC), including novel medications, might reduce the need for colectomy. We performed a retrospective cohort study of adult patients (age 18-64) with UC in the United States to examine time trends for colectomy and biologic use from 2007 to 2016.

Methods: We estimated quarterly rates for colectomy and biologic use using the IQVIA Legacy PharMetrics Adjudicated Claims Database. We used interrupted time series methods with segmented regression to assess time trends with 95% confidence intervals (CIs) for biologic use and colectomy before and after the emergence of newly available biologic therapies in 2014.

Results: Among 93,930 patients with UC, 2275 (2.4%) underwent colectomy from 2007 to 2016. Biologic use rates increased significantly from 2007 to 2016, from 131 per 1000 person-years in 2007 (95% CI, 121 to 140) to 589 per 1000 person-years in 2016 (95% CI, 575 to 604; P < 0.001). Colectomy rates decreased significantly between 2007 and 2016, from 7.8 per 1000 person-years (95% CI, 7.4 to 8.2) to 4.2 per 1000 person-years in 2016 (95% CI, 3.2 to 5.1; P < 0.001). An interruption in 2014 was associated with a positive trend deflection for biologic use (+72 treatments per 1000 person-years per year (95% CI, 61 to 83) and a negative trend deflection for colectomy (-0.76 per 1000 person-years per year; 95% CI, -1.47 to -0.05).

Conclusions: Among commercially insured patients in the United States from 2007 to 2016, biologic use rates increased, colectomy rates decreased, and both trends were impacted by the interruption in 2014. These findings suggest that new biologic therapies may have contributed to decreased colectomy rates.

Keywords: administrative claims; colectomy; inflammatory bowel diseases; interrupted time series; ulcerative colitis.

© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Figures

FIGURE 1.
FIGURE 1.
Incidence rates of colectomy per 1000 person-years among patients with ulcerative colitis in the United States, IQVIA Legacy PharMetrics Adjudicated Claims Database, 2007–2016. P < 0.001.
FIGURE 2.
FIGURE 2.
Segmented trends over calendar time for quarterly incidence rates of (A) biologic use and (B) colectomy per 1000 person-years among patients with ulcerative colitis in the United States, IQVIA Legacy PharMetrics Adjudicated Claims Database, 2007–2016. A, Biologic use: pre-interruption period, P < 0.001; trend deflection at interruption, P < 0.001; postinterruption period, P < 0.001. B, Colectomy: pre-interruption period, P < 0.001; trend deflection at interruption, P = 0.044; postinterruption period, P = 0.005. Pointwise quarterly rates (circles), pre- and postinterruption trend segments (solid lines), and projected postinterruption trend based on pre-interruption trend (dashed lines) are shown separately in each panel for each outcome.
FIGURE 3.
FIGURE 3.
Trends in percentage of patients with claims for biologic therapies over time, among patients with ulcerative colitis in the IQVIA Legacy PharMetrics Adjudicated Claims Database, analyzed by regimen. Other biologics: golimumab, certolizumab, natalizumab.

References

    1. Fumery M, Singh S, Dulai PS, et al. . Natural history of adult ulcerative colitis in population-based cohorts: a systematic review. Clin Gastroenterol Hepatol. 2018;16:343–356.e3.
    1. Jeuring SF, Bours PH, Zeegers MP, et al. . Disease outcome of ulcerative colitis in an era of changing treatment strategies: results from the Dutch population-based IBDSL cohort. J Crohns Colitis. 2015;9:837–845.
    1. Eriksson C, Cao Y, Rundquist S, et al. . Changes in medical management and colectomy rates: a population-based cohort study on the epidemiology and natural history of ulcerative colitis in Örebro, Sweden, 1963-2010. Aliment Pharmacol Ther. 2017;46:748–757.
    1. Parragi L, Fournier N, Zeitz J, et al. ; Swiss IBD Cohort Study Group Colectomy rates in ulcerative colitis are low and decreasing: 10-year follow-up data from the Swiss IBD Cohort Study. J Crohns Colitis. 2018;12:811–818.
    1. Frolkis AD, Dykeman J, Negrón ME, et al. . Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta-analysis of population-based studies. Gastroenterology. 2013;145:996–1006.
    1. Samuel S, Ingle SB, Dhillon S, et al. . Cumulative incidence and risk factors for hospitalization and surgery in a population-based cohort of ulcerative colitis. Inflamm Bowel Dis. 2013;19:1858–1866.
    1. Feagan BG, Rutgeerts P, Sands BE, et al. . GEMINI 1 Study Group Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710.
    1. Sandborn WJ, Su C, Sands BE, et al. . OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–1736.
    1. Kaplan GG, Seow CH, Ghosh S, et al. . Decreasing colectomy rates for ulcerative colitis: a population-based time trend study. Am J Gastroenterol. 2012;107:1879–1887.
    1. Sandborn WJ, Rutgeerts P, Feagan BG, et al. . Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009;137:1250–1260; quiz 1520.
    1. Aratari A, Papi C, Clemente V, et al. . Colectomy rate in acute severe ulcerative colitis in the infliximab era. Dig Liver Dis. 2008;40:821–826.
    1. Clemente V, Aratari A, Papi C, Vernia P. Short term colectomy rate and mortality for severe ulcerative colitis in the last 40 years. Has something changed? Dig Liver Dis. 2016;48:371–375.
    1. Geltzeiler CB, Lu KC, Diggs BS, et al. . Initial surgical management of ulcerative colitis in the biologic era. Dis Colon Rectum. 2014;57:1358–1363.
    1. Stempel DA, Mauskopf J, McLaughlin T, et al. . Comparison of asthma costs in patients starting fluticasone propionate compared to patients starting montelukast. Respir Med. 2001;95:227–234.
    1. Kappelman MD, Rifas-Shiman SL, Kleinman K, et al. . The prevalence and geographic distribution of Crohn’s disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007;5:1424–1429.
    1. Bernstein CN, Blanchard JF, Rawsthorne P, Wajda A. Epidemiology of Crohn’s disease and ulcerative colitis in a central Canadian province: a population-based study. Am J Epidemiol. 1999;149:916–924.
    1. Kulaylat AS, Kulaylat AN, Schaefer EW, et al. . Association of preoperative anti-tumor necrosis factor therapy with adverse postoperative outcomes in patients undergoing abdominal surgery for ulcerative colitis. JAMA Surg. 2017;152:e171538.
    1. Peery AF, Cools KS, Strassle PD, et al. . Increasing rates of surgery for patients with nonmalignant colorectal polyps in the United States. Gastroenterology. 2018;154:1352–1360.e3.
    1. Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45:613–619.
    1. Shadish W, Cook T, Campbell D.. Experimental and Quasi-Experimental Designs for Generalized Causal Inference. 2nd ed. Boston: Houghton-Mifflin; 2001.
    1. Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27:299–309.
    1. Gillings D, Makuc D, Siegel E. Analysis of interrupted time series mortality trends: an example to evaluate regionalized perinatal care. Am J Public Health. 1981;71:38–46.
    1. Piegorsch W, Bailer J.. Nonlinear Regression. 1st ed. Chichester, UK:John Wiley & Sons, Ltd; 2005.
    1. Brookhart MA, Rothman KJ. Simple estimators of the intensity of seasonal occurrence. BMC Med Res Methodol. 2008;8:67. doi:10.1186/1471-2288-8-67
    1. Nam J-m. Efficient method for identification of cyclic trends in incidence. Comm Statist Theory Methods. 1983;12:1053–1068.
    1. DURBIN J, WATSON GS. Testing for serial correlation in least squares regression. I. Biometrika. 1950;37:409–428.
    1. Berg DR, Colombel JF, Ungaro R. The role of early biologic therapy in inflammatory bowel disease. Inflamm Bowel Dis. 2019;15:1896–1905.
    1. Langholz E, Munkholm P, Davidsen M, Binder V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology. 1994;107:3–11.
    1. Murthy SK, Begum J, Benchimol EI, et al. . Introduction of anti-TNF therapy has not yielded expected declines in hospitalisation and intestinal resection rates in inflammatory bowel diseases: a population-based interrupted time series study. Gut. In press.
    1. Reich KM, Chang HJ, Rezaie A, et al. . The incidence rate of colectomy for medically refractory ulcerative colitis has declined in parallel with increasing anti-TNF use: a time-trend study. Aliment Pharmacol Ther. 2014;40:629–638.
    1. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. . ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384–413.
    1. Uchino M, Ikeuchi H, Hata K, et al. . Changes in the rate of and trends in colectomy for ulcerative colitis during the era of biologics and calcineurin inhibitors based on a Japanese nationwide cohort study. Surg Today. In press.
    1. Yu H, MacIsaac D, Wong JJ, et al. . Market share and costs of biologic therapies for inflammatory bowel disease in the USA. Aliment Pharmacol Ther. 2018;47:364–370.
    1. Kolehmainen S, Lepisto A, Farkkila M. Impact of anti-TNF-alpha therapy on colectomy rate and indications for colectomy in ulcerative colitis: comparison of two patient cohorts from 2005 to 2007 and from 2014 to 2016. Scand J Gastroenterol. 2019;54:707–711.
    1. Laine L, Kaltenbach T, Barkun A, et al. . SCENIC Guideline Development Panel SCENIC international consensus statement on surveillance and management of dysplasia in inflammatory bowel disease. Gastroenterology. 2015;148:639–651.e28.
    1. Regueiro M, Click B, Anderson A, et al. . Reduced unplanned care and disease activity and increased quality of life after patient enrollment in an inflammatory bowel disease medical home. Clin Gastroenterol Hepatol. 2018;16:1777–1785.
    1. Panaccione R, Ghosh S, Middleton S, et al. . Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146:392–400.e3.
    1. Peyrin-Biroulet L, Sandborn W, Sands BE, et al. . Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110:1324–1338.
    1. Ungaro R, Colombel JF, Lissoos T, Peyrin-Biroulet L. A treat-to-target update in ulcerative colitis: a systematic review. Am J Gastroenterol. 2019;114:874–883.
    1. Colombel JF, D’Haens G, Lee WJ, Petersson J, Panaccione R. Outcomes and strategies to support a treat-to-target approach in inflammatory bowel disease: a systematic review. J Crohns Colitis. In press.
    1. Romberg-Camps MJ, Dagnelie PC, Kester AD, et al. . Influence of phenotype at diagnosis and of other potential prognostic factors on the course of inflammatory bowel disease. Am J Gastroenterol. 2009;104:371–383.

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