Healthcare Resource Utilization In Patients With Moderate To Severe Crohn’s Disease: A Brazilian Real World Study 1
Decimoni TC, 1Sztajnbok S, 2Feitosa MR, 2Parra RS
1 Takeda
Pharmaceuticals Brazil, São Paulo, Brazil; 2 Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto – USP, Ribeirão Preto, Brazil
INTRODUCTION • Crohn’s Disease (CD) is a chronic disease characterized by episodes of relapse and remission, which translate into relevant healthcare and economic burden.1,2 • There is a lack o f ep idemiological da ta in Brazil regarding CD , especially the burden and economic impact of these diseases to the health care system. • Substantial use o f healthcare resources may suggest that therapies used are suboptimal.3 • The RI S E BR study was imple mented in Brazil to provide real world data in the context of in flam matory bowel disease ( IBD), focused on CD and ulcerative coli tis (UC), to describe the sociodemographic and clinical aspects, the treat ment pat terns, pa tient-reported outcomes and the use of health resources for disease management. • We hereby describe sociodemographic and clinical features o f patients with moderate to severe CD, at enroll ment , as well as determine the use o f healthcare resources, 3-year retrospectively, in this setting in Brazil.
Treatments for CD at Day 1
Use of healthcare resources by biological treatment
• At Day 1, 251 (95.1%) pat ients were taking treat ment for CD, o f which 39.4% were b iological therapy and 37 .8 % were immunosuppressants (Figure 2). • Forty-five (17.0%) patients changed their treatment at Day 1. • The most com mon biological therapy was inflixi mab (55.4 %) , followed by adali mumab (41.5 %), vedolizumab (2.1 %), certolizumab (0.5%) and ustekimumab (0.5 %). There were patien ts who used more than one biological therapy. • Azathioprine was the most frequent immunosuppressant (92.5%). • The mean number o f treatmen ts per ind ividual was 1 .9±1.0 (range: 1 to 7).
Figure 2. Therapy ongoing at Day 1
• Approximately 71% of the pa tients changed trea tment for CD a t least once over the 3-year period previous to Day 1. • The majori ty of treat ment changes corresponded to discontinuations (43.5% of treat ment changes), wi th the h ighest proportion occurring with antibio tic therapy (30.5 %). In general, poor e ffectiveness was the main reason for dose change (20.3%). • Inflixi mab was the biolog ic therapy with the highest rate o f discontinuations (52.8 %) and with the highest nu mber of dose changes (77.4%). • Most of dose changes with non-biologic therapy occurred with corticosteroids (41.8%).
Study population • ≥18 years old, who provided written informed consent.
Statistics • Comparison between biological vs. non-biological groups was performed using Mann-Whi tney tes t (quant ita tive variables) and ChiSquare test or Fisher’s exact test (qualitative variables). • Tests were two-tailed with s tatist ical significance set a t 0.05 . Stat istical analysis was performed using SA S® (version 9.4, SA S Institute Inc, Cary).
RESULTS • Sample characterization is showed in Table 1. Table 1. Socio-demographic and Crohn’s Disease (CD) characterization CD Patients (n= 264) Prevalence of moderate to severe CD, n (%) 118, 44.7% 95% CI (38.7% – 50.7%) Age (years) Mean ± SD 42.9 ± 13.0 Median [Min – Max] 41.0 [20.0 - 72.0] Gender, n (%) Female 143 (54.2%) Weight (kg) Mean ± SD 69.0 ± 14.5 Median [Min – Max] 66.5 [32.0 – 115.0] BMI (kg/m2 ) Mean ± SD 25.1 ± 4.7 Median [Min – Max] 24.7 [15.2 – 44.0] Time since diagnosis of moderate to severe CD (years) Mean ± SD 8.0 ± 6.3 Median [Min – Max] 6.0 [0.0 – 30.0] Age at CD diagnosis (years) Mean ± SD 31.7 ± 11.4 Median [Min – Max] 29.0 [12.0 – 70.0] Any relevant medical history, comorbidity or extra 143 (54.2%*) intestinal manifestation, n (%) Arthralgia 23 (7.5%) Hypertension 37 (12.1%) SD: Standard Deviation; Min: Minimum ; Max: Maximum; BMI: Body Mass Index; 95% CI: 95% confidence interval. * Of the patients with extra-intestinal manifestations, arthralgia was the most frequent condition (25%).
• The rate of hospitaliza tion due to CD was higher among pat ients treated with biologics than non- treated (40.6 % versus 30.4% , respectively; p = 0.163).
Medical appointments
• The mean number o f these tests was stat istically signif icant higher for patients treated with biological therapies (p=0.037).
CD treatment changes in the previous 3 years (before Day 1)
• Diagnosis of moderate to severe IBD at least 6 months before Day 1 according the clinical or endoscopic criteria. • Participants presenting indetermina te or no t classified coli tis, as we ll as, with current or previous participat ion in interventional clinical trials (within the last 3 years) were excluded.
Hospitalizations
Imaging and laboratory tests
Design
Figure 1. Study scheme
• Overall, 27.5 % of pat ients treated wi th biological therapy underwen t surgery, with fistulecto my/anal fistulecto my corresponding to 20.8 % of a ll surgeries - Table 2 . Among pa tients not treated with b iologica l therapy, two (16 .7%) surgeries were partial colecto my and two (16.7%) were fistulectomy/anal fistulectomy .
• The mean number of medical appoint ments was significantly higher for pa tients treated wi th biological trea tments than non- treated (p=0.003). • The proportion of patien ts who changed CD treat ment during the medical appoin tmen ts was si milar be tween treat ment groups (16.1 % for biological therapy versus 17.6% for non-biological therapy).
METHODS • Multicenter, observational study conducted a t 14 Brazilian centers . The study included a 3-year longi tudinal retrospective analysis, to characterize the I BD managemen t (trea tments and use of healthcare resources) - F igure 1. Patien ts were enrolled consecutively from October/2016 to February/2017 based on a scheduled appointmen t with their physician (Day 1).
Surgeries
Use of health resources in the previous 3 years (before Day 1) The use o f heal th resources in the previous 3 years (before Day 1 appointment) is illustrated in Figure 3. Medical appointments • Overall, 3192 medical appointments were attended by 263 patients. • The mean nu mber of medical appoint ments per pat ient was 12.1±6.8. • Over 90% of appointments were with an IBD specialist.
Table 2. Use of healt hcare resources in CD according to biological treatment over a 3-yearperiod Biological Non-Biological P-value Treatment Treatment (n=207) (n=56) ¥ Previous surgery forCD, n (%) 57 (27.5%) 10 (17.9%) 0.140 (CS) Number of surgeries Mean ± SD 1.7 ± 0.95 1.2 ± 0.42 Median [Min – Max] 1.0 [1.0 – 5.0] 1.0 [1.0 – 2.0] 0.108 (MW) Previous hospitalization due to 84 (40.6%) 17 (30.4%) 0.163 (CS) CD, n (%) Number of hospitalizations Mean ± SD 1.7 ± 0.93 1.6 ± 0.62 Median [Min – Max] 1.0 [1.0 – 5.0] 2.0 [1.0 – 3.0] 0.868 (MW) Previous medical 207 (100.0%) 55 (98.2%) 0.213 (FE) appointments due to CD, n (%) Number of medical appointments Mean ± SD 12.8 ± 7.17 9.8 ± 4.58 Median [Min – Max] 12.0 [1.0 – 45.0] 10.0 [1.0 – 23.0] 0.003 (MW) Previous imaging and 55 (98.2%) >0.999 (FE) laboratory testingdue to CD, n 204 (98.6%) (%) Number of imagingand laboratory tests Mean ± SD 22.9 ± 18.13 18.3 ± 17.53 Median 20.5* 15.0 † 0.037 (MW) [Min – Max] [1.0 – 143.0] [1.0 – 124.0] Any change in CD treatment, n 427 (16.1%) 95 (17.6%) 0.417 (CS) (%) SD: Standard Devia tion; Min : Minimum; Max: Maximum; CS: Chi-square test; FE: Fisher exact te st; MW: Mann-Whitney test. ¥ One missin g; *Three missing; † One missing.
CONCLUSIONS
Imaging and laboratory tests • A tota l of 5674 imag ing or laboratory tests were perfor med by 260 patients. • The average number of imag ing and laboratory tests per patien t was 21.8±18.1. Hemogra m was the most frequent test (40.8 %), followed by C-reactive protein (31.2%). Hospitalizations • Overall, 38.3% of CD patients required hospitalization. • A total of 168 hospitalizations occurred among 101 patients. • The mean nu mber of hospital izations was 1.7±0 .89 and the mean duration of hospitalization was 12.0±17.1 days. Surgeries • 67 (25.4 %) pat ients underwent 108 surgeries over the 3-year period . The mean number of surgeries per patient was 1.6±0.9. • The majority (20.4 %) of surgeries were anal procedures (fistulectomy).
• Moderate to severe CD was associated with substantial heal thcare resource utilization in Brazil. • Biologics and i mmunosuppressants were the most frequen t therapies at Day 1. The most com mon bio logical therapy was infliximab (55.4 %), fol lowed by adal imu mab (41.5 %), vedolizumab (2.1%), certolizu mab (0.5%) and ustekimu mab (0.5 %). Use o f multiple biologics by each patient may have occurred. • In general, poor effectiveness was the main reason for dose change. • The mean nu mber o f medical appoint ments, i maging and labora tory tests was sta tistically signi ficantly higher among pat ients treated w ith biological treatmen ts versus non-treated. This could be explained because of the greater severity o f d isease in those trea ted w ith biologics and maybe also suggesting tha t they were treated rather late, wi th the late in troduction of bio logic therapy over the course o f disease. • On average, there were 2 hospitalizations per patient, wi th average duration of 12 .0±17.1 days, which may be ano ther indicator o f suboptimal therapy. • One quarter o f the pa tients required surgeries over a period of 3 years, with fistulectomy being the most common surgery.
DISCLOSURES & ACKNOWLEDGEMENTS This s tudy was un der take n wit h th e fi nanci al su ppo rt of T aked a Ph ar mace uticals Brazil. A t the time o f t he stu dy, T assia Deci mo ni and Se rgio Sztaj nbok we re e mploy ees of T aked a Pharm ace uticals Br azil. Eur otrial s pro vide d sup por t in con ducti ng th e res earc h an d medic al wri ting assist anc e. We th ank A nto nio Sca fut o Scot ton, Cristi na Flo res, Cyrl a Zalt man, G enoil e Oliv eira, He da A ma rant e, José Mi guel Par ent e, Ligia Sassaki , M ari a d e Lour des Fe rra ri, Mau ro Baf utto , Od ery Ra mos , Rob ert o Kaise r, Rog éri o Par ra, Se nde r Miszputen and Wilson Catapani for their contribution in the study.
REFERENCES Note: Year 3is theclosest to the medical appointment at Day1. Figure 3. Yearly use of healthcare resources over a 3-year period(before Day 1)
1. Burisch J, Jess T, Martinato M, Lakatos PL; ECCO-EpiC om. The burden of inflammatorybowel disease in Europe. J CrohnsColitis. 2013;7(4):322-37. 2. Ponder A, Long MD. A clinical review of recent findings in th e epid emiolo gy of inflammatorybowel disease. Clin Epidemiol. 2013;5:237-47. 3. van Deen WK, van Oijen MG, Myers KD, et al. A nationwide 2010-2012 analysis of U.S. health care utilization in inflammatory bowel diseases. Inflamm BowelDis . 2014;20(10):1747-53.
Presented at the ISPOR 20 th Annual European Congress • Date, 4-8 November 2017 • Glasgow, Scotland Contact: Rogério Serafim Parra, MD - E-mail:
[email protected]
