Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory disorders without a cure, and thus while the overall incidence of inflammatory bowel disease (IBD) is relatively stable, the prevalence of IBD continues to increase as the IBD population ages. Approximately one third of new cases of CD are diagnosed in elderly patients,1 which also contributes to the growing segment of older individuals living with IBD.
While the treatment of older patients with IBD should be similar to that of younger patients, multiple practical issues may ultimately affect therapy decisions. Polypharmacy is a significant issue for many older patients, and in 1 retrospective study, 94% of patients age 65 or older with IBD were taking 3 or more medications.2 The comparative safety of therapies in older patients is also a concern. An increased risk for multiple adverse effects of IBD-specific therapies have been identified in older populations, including lymphoma,3–5 nonmelanoma skin cancer,6,7 and infections such as herpes zoster.8,9 In addition, comorbidities may preclude the use of certain therapies, such as anti–tumor necrosis factor (TNF) therapies in patients with advanced heart failure.10 However, large-scale evaluations of therapy utilization in administrative claims data, in particular comparisons between older patients and younger populations, have been limited given that many patients over the age of 65 receive insurance via Medicare11,12 thus altering apparent prescription patterns in these data sources.
To evaluate medication utilization patterns among patients over the age of 65, we utilized an observational, multicenter longitudinal cohort from 34 academic and community practices. The primary aim of this study was to analyze medication use patterns among older patients and to identify potential differences in utilization patterns among patients older than age 65 in comparison to younger age groups.
MATERIALS AND METHODS
Data Source
TARGET-IBD is a longitudinal, multicenter, observational cohort. For this study, data were collected from 34 sites (n=22 academic institutions and n=12 community practices) between July 1, 2017, and February 18, 2020. The sites were selected to include a variety of geographic locations, urban and rural settings, and varying levels of research prominence. The goal was to make this combination of academic and community sites as generalizable as possible, recognizing that TARGET-IBD would not be a population-based study. The TARGET observational cohorts are designed to describe the real-world diagnosis, management, and natural course of specific diseases. Any patient with the following characteristics was eligible for inclusion in the TARGET-IBD cohort: (1) a diagnosis of CD, UC, or indeterminate colitis (assessed by a treating physician) and (2) receiving any prescription therapy as a treatment for IBD. Those patients who were unable or unwilling to provide written informed consent were enrolled in any interventional study or clinical trial of a therapy for IBD, or who had a history of a total abdominal colectomy for UC or indeterminate colitis were excluded from the study.
The protocol for TARGET-IBD has been described previously.13 Briefly, up to 3 years of retrospective data is abstracted from the medical records of consented patients at the time of enrollment. Patients are then followed prospectively. All treatment decisions and clinical follow-up are determined by the treating physician. Medical records from each participating center are uploaded into a secure data repository, after which abstractors collect information on demographics, disease characteristics, medication utilization, laboratory testing, pathology results, and comorbidities. Enrolled participants may opt to provide additional information via self-administered patient-reported outcome (PRO) measures.
Outcomes of Interest
The primary goal of this study was to compare use patterns of medication use at the time of enrollment among older patients with IBD to those among younger age groups. Treatment utilization patterns were stratified by the subtype of IBD (CD or UC) and the age distribution of patients. Pediatric patients were excluded and age at study entry was analyzed in the following categories: 18 to 29, 30 to 49, 50 to 65, and above 65 years. Those patients above 65 years represented the older age group for all comparisons.
Medication utilization was analyzed at the time of enrollment. In the analyses of medications, agents were analyzed by class of therapy (aminosalicylates, anti-integrins, anti-interleukin 12/23, anti-TNF, Janus kinase inhibitors, methotrexate, and thiopurines).
Covariates
Other demographic information including sex, race, ethnicity, body mass index and type of insurance were obtained from a review of the redacted medical records. Medical comorbidities were also obtained, and those comorbidities that might contribute to the selection of a particular therapy for the treatment of CD or UC were analyzed. We used the Manitoba IBD Index to assess disease symptom severity among participants who completed PROs at baseline. The Manitoba IBD Index is a qualitative measure of disease activity based upon self-report frequency of symptoms (never, rarely, occasionally, sometimes, often, constantly).14 For analysis, we used the dichotomous version of this measure to define active disease (occasionally, sometimes, often, or constantly experience symptoms) versus inactive disease (never or rarely experience symptoms).14
Statistical Analysis
All continuous variables were summarized using the median and interquartile range. Categorical variables were presented as proportions and compared using the Fisher exact and χ2 testing as appropriate. In the initial univariate analyses, pairwise comparisons were utilized to compare the relationship between patients above 65 years and all other age categories. The odds of IBD-specific therapy use among patients older than age 65 were evaluated by therapy class using bivariate and multivariable logistic regression models to adjust for potential confounders. All covariates included in the multivariable analyses were identified a priori based on a presumed association with therapy choices or the disease course among patients with CD or UC. All statistical analyses were performed using SAS (version 9.4) statistical software (SAS Institute, Cary, NC). The study protocol was approved by the Institutional Review Boards of all participating institutions.
Ethical Statement
Written informed consent was obtained from the participants of TARGET-IBD.
RESULTS
We identified 2980 patients with IBD (61% CD), who were treated during the study period. The median age of the patients treated was 43 years (interquartile range, 31 to 58 y) and 54% were female (Table 1). Among the 2980 patients, 84% of patients were white, and 58% received treatment at an academic site. In an evaluation of insurance coverage, 78% had private insurance, 16% had Medicare, and 5% had Medicaid insurance.
TABLE 1 -
Comparison of Demographics and Clinical Characteristics Among Patients in the TARGET-IBD Cohort
|
Participant Type [n (%)] |
|
| Summary |
Ulcerative Colitis (N=1148) |
Crohn’s Disease (N=1832) |
All Participants (N=2980) [n (%)] |
| Site type |
| Academic |
565 (49.2) |
1175 (64.1) |
1740 (58.4) |
| Community |
583 (50.8) |
657 (35.9) |
1240 (41.6) |
| Age at study entry by category*
|
| 18-29 |
207 (18.0) |
442 (24.1) |
649 (21.8) |
| 30-49 |
442 (38.5) |
744 (40.6) |
1186 (39.8) |
| 50-65 |
298 (26.0) |
426 (23.3) |
724 (24.3) |
| >65 |
201 (17.5) |
220 (12.0) |
421 (14.1) |
| Sex |
| Female |
599 (52.2) |
1000 (54.6) |
1599 (53.7) |
| Male |
549 (47.8) |
832 (45.4) |
1381 (46.3) |
| Race |
| White |
963 (83.9) |
1549 (84.6) |
2512 (84.3) |
| Black or African American |
60 (5.2) |
144 (7.9) |
204 (6.8) |
| American Indian or Alaska Native |
2 (0.2) |
3 (0.2) |
5 (0.2) |
| Native Hawaiian or Other Pacific Islander |
3 (0.3) |
2 (0.1) |
5 (0.2) |
| Asian |
37 (3.2) |
34 (1.9) |
71 (2.4) |
| Other |
25 (2.2) |
32 (1.7) |
57 (1.9) |
| Not reported |
58 (5.1) |
68 (3.7) |
126 (4.2) |
| ethnicity |
| Hispanic or Latino |
46 (4.0) |
56 (3.1) |
102 (3.4) |
| Not Hispanic or Latino |
1009 (87.9) |
1681 (91.8) |
2690 (90.3) |
| Other |
8 (0.7) |
8 (0.4) |
16 (0.5) |
| Not reported |
85 (7.4) |
87 (4.7) |
172 (5.8) |
| BMI at enrollment (kg/m2) |
| Median (n) |
27.0 (1112) |
26.0 (1758) |
26.0 (2870) |
| Minimum-maximum |
16-61 |
13-71 |
13-71 |
| Duration of disease (y) |
| Median (n) |
8.0 (1028) |
12.0 (1672) |
10.0 (2700) |
| Minimum-maximum |
0-58 |
0-64 |
0-64 |
| Family history of CD or UC |
| No |
637 (55.5) |
973 (53.1) |
1610 (54.0) |
| Yes |
147 (12.8) |
342 (18.7) |
489 (16.4) |
| Unknown |
364 (31.7) |
517 (28.2) |
881 (29.6) |
| Tobacco use |
| Current everyday smoker |
21 (1.8) |
131 (7.2) |
152 (5.1) |
| Current some day smoker |
14 (1.2) |
43 (2.3) |
57 (1.9) |
| Smoker, current status unknown |
3 (0.3) |
12 (0.7) |
15 (0.5) |
| Former smoker |
298 (26.0) |
448 (24.5) |
746 (25.0) |
| Never smoker |
783 (68.2) |
1163 (63.5) |
1946 (65.3) |
| Unknown |
29 (2.5) |
35 (1.9) |
64 (2.1) |
| Insurance type at enrollment |
| Private |
904 (78.7) |
1409 (76.9) |
2313 (77.6) |
| Medicare |
176 (15.3) |
286 (15.6) |
462 (15.5) |
| Medicaid |
47 (4.1) |
101 (5.5) |
148 (5.0) |
| Other |
33 (2.9) |
33 (1.8) |
66 (2.2) |
| Supplemental |
17 (1.5) |
49 (2.7) |
66 (2.2) |
| Unknown |
15 (1.3) |
45 (2.5) |
60 (2.0) |
| Uninsured |
7 (0.6) |
15 (0.8) |
22 (0.7) |
| Not reported |
1 (0.1) |
3 (0.2) |
4 (0.1) |
*Age calculated based on year of consent minus birth year.
When examining medication use patterns, those patients older than 65 years were significantly more likely to utilize aminosalicylate monotherapy when compared with younger age groups. In pairwise comparisons, this pattern was true when evaluating all patients with IBD over the age of 65 compared with 18- to 29-year-olds (34.2% vs. 13.7%, P<0.001), 30- to 49-year-olds (34.2% vs. 20.9%, P<0.001), and 50- to 65-year-olds (34.2% vs. 22.4%, P<0.001, Table 2). Patients older than 65 years were also significantly more likely to use aminosalicylate monotherapy when evaluating CD (19.5%) and UC (50.2%) separately (all P<0.008 in pairwise comparisons with younger age groups with the exception of age 30 to 49 vs. above 65 y in UC, Supplementary Tables 1, 2, respectively, Supplemental Digital Content 1, https://links.lww.com/JCG/A735). When the use of sulfasalazine was examined separately from other aminosalicylates, sulfasalazine use was also more likely in older patients when compared with younger age groups (Supplementary Tables 3, 4, 5, Supplemental Digital Content 1, https://links.lww.com/JCG/A735). In an analysis of all patients with IBD, those patients older than 65 years were also significantly less likely to utilize anti-TNF monotherapy compared with younger age groups (all P<0.008, Table 2). Patients above 65 were also more likely to be on steroid monotherapy as compared with patients age 18 to 65 (4.8% vs. 2.5%, P=0.01).
TABLE 2 -
Inflammatory Bowel Disease–specific Medication Utilization at the Time of Enrollment Into the TARGET-IBD Cohort, a Comparison Across Age Categories
|
Age at Enrollment [n (%)] |
|
|
|
| IBD Treatments at Enrollment |
18-29 (N=649) |
30-49 (N=1186) |
50-65 (N=724) |
>65 (N=421) |
P (18-29 vs. >65) |
P (30-49 vs. >65) |
P (50-65 vs. >65) |
| Aminosalicylate monotherapy |
89 (13.7) |
248 (20.9) |
162 (22.4) |
144 (34.2) |
<0.0001 |
<0.0001 |
<0.0001 |
| Thiopurine monotherapy |
28 (4.3) |
57 (4.8) |
34 (4.7) |
26 (6.2) |
0.1744 |
0.2755 |
0.2789 |
| Methotrexate monotherapy |
3 (0.5) |
14 (1.2) |
5 (0.7) |
3 (0.7) |
0.5923 |
0.4203 |
0.9657 |
| Anti-TNF monotherapy |
204 (31.4) |
255 (21.5) |
113 (15.6) |
42 (10.0) |
<0.0001 |
<0.0001 |
0.0073 |
| Anti-integrin monotherapy |
31 (4.8) |
66 (5.6) |
41 (5.7) |
24 (5.7) |
0.5038 |
0.9171 |
0.9788 |
| Anti-IL-12/23 monotherapy |
36 (5.5) |
65 (5.5) |
39 (5.4) |
11 (2.6) |
0.0222 |
0.0173 |
0.0268 |
| JAK inhibitor monotherapy |
3 (0.5) |
7 (0.6) |
1 (0.1) |
3 (0.7) |
0.5923 |
0.7839 |
0.1123 |
| Anti-TNF+thiopurine |
46 (7.1) |
106 (8.9) |
54 (7.5) |
19 (4.5) |
0.0851 |
0.0036 |
0.0493 |
| Anti-TNF+methotrexate |
25 (3.9) |
45 (3.8) |
27 (3.7) |
11 (2.6) |
0.2723 |
0.2563 |
0.3094 |
| Anti-integrin+thiopurine |
17 (2.6) |
22 (1.9) |
13 (1.8) |
6 (1.4) |
0.1884 |
0.5627 |
0.6363 |
| Anti-integrin+methotrexate |
8 (1.2) |
10 (0.8) |
3 (0.4) |
7 (1.7) |
0.5591 |
0.1581 |
0.0287 |
| Anti-IL-12/23+thiopurine |
12 (1.8) |
19 (1.6) |
6 (0.8) |
0 (0.0) |
0.0050 |
0.0090 |
0.0612 |
| Anti-IL-12/23+methotrexate |
14 (2.2) |
15 (1.3) |
13 (1.8) |
2 (0.5) |
0.0268 |
0.1738 |
0.0582 |
| Biologic+aminosalicylate |
79 (12.2) |
142 (12.0) |
102 (14.1) |
39 (9.3) |
0.1380 |
0.1310 |
0.0166 |
| Thiopurine/methotrexate+aminosalicylate |
37 (5.7) |
85 (7.2) |
67 (9.3) |
32 (7.6) |
0.2167 |
0.7685 |
0.3374 |
IBD indicates inflammatory bowel disease; IL, interleukin; JAK, Janus kinase; TNF, tumor necrosis factor.
In a multivariable analysis controlling for the site of care, sex, and race, younger patients with UC were significantly less likely to utilize aminosalicylate monotherapy at the time of enrollment when compared with patients older than 65 years [age 18 to 29: adjusted odds ratio (aOR)=0.51, 95% confidence interval (CI): 0.33-0.78, Table 3]. In a similar evaluation of patients with CD, patients in multiple younger age categories were significantly less likely to use aminosalicylate monotherapy when compared with patients over age 65 (age 18 to 29: aOR=0.31, 95% CI: 0.18-0.52; age 30 to 49, aOR=0.38, 95% CI: 0.25-0.60; age 50 to 65: aOR=0.54, 95% CI: 0.34-0.86). In these multivariable analyses, patients with both UC and CD treated at academic sites were significantly less likely to receive aminosalicylate monotherapy compared with patients treated at community sites.
TABLE 3 -
Multivariable Analysis Evaluating Odds of Aminosalicylate Monotherapy Use Among Patients With Crohn’s Disease and Ulcerative Colitis in the TARGET-IBD Cohort
|
Adjusted OR (95% CI) |
| Characteristic |
Crohn’s Disease |
Ulcerative Colitis |
| Age (y) |
| 18-29 |
0.31 (0.18-0.52) |
0.51 (0.33-0.78) |
| 30-49 |
0.38 (0.25-0.60) |
0.84 (0.59-1.19) |
| 50-65 |
0.54 (0.34-0.86) |
0.63 (0.43-0.92) |
| >65 |
Reference |
Reference |
| Academic site of care |
0.58 (0.42-0.81) |
0.60 (0.46-0.77) |
| Female sex |
0.89 (0.65-1.22) |
0.93 (0.72-1.19) |
| Race |
| White |
1.03 (0.62-1.71) |
0.82 (0.56-1.20) |
| Nonwhite |
Reference |
Reference |
All variables included in the multivariable analysis are depicted above.
When comparing the use of anti-TNF monotherapy among patients with CD of different age groups after controlling for potential confounders, patients in younger age categories were significantly more likely to use anti-TNF monotherapy compared with patients above 65 years (Table 4). In these analyses, patients age 18 to 29 demonstrated the greatest odds of using anti-TNF monotherapy (aOR=3.87, 95% CI: 2.47-6.06). There were no significant differences in the odds use of combination therapy (anti-TNF therapy and an immunomodulator) among patients with CD by age category, after adjusting for other covariates (Supplementary Table 6, Supplemental Digital Content 1, https://links.lww.com/JCG/A735).
TABLE 4 -
Multivariable Analysis Evaluating Odds of Anti–Tumor Necrosis Factor Alpha Monotherapy Use Among Patients With Crohn’s Disease and Ulcerative Colitis in the TARGET-IBD Cohort
|
Adjusted OR (95% CI) |
| Characteristic |
Crohn’s Disease |
Ulcerative Colitis |
| Age (y) |
| 18-29 |
3.87 (2.47-6.06) |
2.68 (1.29-5.58) |
| 30-49 |
2.46 (1.59-3.79) |
1.67 (0.84-3.34) |
| 50-65 |
1.77 (1.12-2.82) |
1.21 (0.57-2.58) |
| >65 |
Reference |
Reference |
| Academic site of care |
1.14 (0.90-1.43) |
1.55 (1.01-2.37) |
| Female sex |
0.87 (0.70-1.07) |
0.90 (0.60-1.34) |
| Race |
| White |
1.21 (0.87-1.68) |
0.96 (0.53-1.76) |
| Nonwhite |
Reference |
Reference |
All variables included in multivariable analysis are depicted above.
CI indicates confidence interval; OR, odds ratio.
Among patients with UC, patients age 18 to 29 were significantly more likely to utilize anti-TNF monotherapy when compared with patients older than 65 at enrollment (aOR=2.68, 95% CI: 1.29-5.58). In addition, patients age 50 to 65 with UC were more likely to use combination therapy with an anti-TNF and an immunomodulator compared with patients age above 65 years (aOR=2.21, 95% CI: 1.06-4.60, Supplementary Table 6, Supplemental Digital Content 1, https://links.lww.com/JCG/A735). Patients treated at academic sites were more likely to utilize anti-TNF as monotherapy (aOR=1.55, 95% CI: 1.01-2.37) and in combination with an immunomodulator (aOR=1.74, 95% CI: 1.13-2.67) when compared with patients treated at a community site.
In the subset of participants who completed PROs (n=1146), no statistically significant differences in the patterns of disease symptom severity were observed by age. Although in general, older patients were less likely to report active symptoms than patients age 65 or younger (Supplementary Table 7, Supplemental Digital Content 1, https://links.lww.com/JCG/A735). Overall, 44% of UC patients age above 65 on a biological-reported symptoms consistent with active disease, compared with 60% of younger patients (P=0.21). Similarly, 51% of older UC patients on a nonbiologic drug reported active symptoms compared with 62% of younger patients (P=0.16). In CD, 59% of older patients on a biologic had active disease versus 71% of younger patients (P=0.19). A similar proportion of older (63%) and younger (66%) patients with CD on nonbiologics indicated their symptoms were active (P=0.76).
DISCUSSION
In this multicenter cohort of over 2900 patients, we demonstrated that older patients are significantly more likely to receive aminosalicylate monotherapy as a treatment for both CD and UC. In addition, patients with CD and UC above 65 years were significantly less like to receive monotherapy with an anti-TNF when compared with patients from younger age groups. These patterns were demonstrated within a large, diverse patient population, recruited from both community and academic practices throughout the United States. The treatment patterns demonstrated are not nationally representative but do provide new information regarding IBD-specific utilization patterns among older patients with IBD when compared with younger age groups.
Understanding medication utilization patterns among older patients with CD and UC will be a critical component to future evaluations of clinical outcomes in this population. As the global population ages, an increase in the prevalence of IBD among older patients is also expected.15 Multiple factors may influence the initial decisions in the treatment of older patients with IBD. Prior studies have indicated that older patients with CD may be significantly more likely to be misdiagnosed when compared with younger patients. Despite the potentially increased rates of diagnostic delay,16,17 a recent systematic review and meta-analysis18 and prior large cohort studies19 have indicated that older patients with IBD may be more likely to present with the less complicated disease, which likely also influences both provider and patient decision making when choosing an initial therapy for the treatment of CD or UC. In our study, patients over age 65 were less likely to report symptoms of active disease than their younger counterparts, irrespective of disease type and drug class, but the differences were not statistically significant. In other evaluations, however, despite similar rates of surgery for CD, patients with late-onset CD were significantly less likely to receive treatment with immunomodulators or biologics.20 Similarly, in a nationwide cohort study, those patients with a first diagnosis of IBD at age 60 or older demonstrated an increased absolute risk of bowel surgery when compared with the general population.21 In the same analysis, patients with older age at diagnosis also demonstrated an increased use of steroids and a decreased use of biologics and immunomodulators.
In the separate analyses of patients with CD and UC, patients older than age 65 were significantly more likely to use aminosalicylate monotherapy when compared with younger age groups. Aminosalicylates are often the recommended first-line therapy for the treatment of mild to moderate UC.22 However, there is a lack of evidence to support their routine use in the treatment of CD.10 Despite society guidelines recommending avoidance of aminosalicylates in the treatment of CD, prior studies have also demonstrated a relatively high frequency of use of aminosalicylate therapy in this population.2,19,23 The reasons for the high rates of aminosalicylate utilization among older individuals are likely multifactorial. Given the relative paucity of adverse effects attributed to aminosalicylate therapy, there may be an increased perception of aminosalicylate therapies as safer alternatives to more potent immunomodulator or biologic therapies. Similarly, patients may take comfort in the routine of an oral formulation of therapy as compared with injectable or infusion-based therapy. Payor requirements and/or restrictions may also play a role. Ultimately, longitudinal analyses in this cohort will be necessary to evaluate the relative effectiveness and safety of these approaches, particularly given the preliminary PRO data in these analyses.
Older patients are also more likely to be prescribed long-term corticosteroid therapy, often as a maintenance agent.2,24 The continued use of corticosteroids among older patients with IBD has also been associated with worsened PROs.25 Given these concerns, as well as an increased risk of polypharmacy,26 the effectiveness of each therapy should be consistently reassessed in follow-up visits, including the need for continued aminosalicylate therapy during concomitant therapy with a biologic.27,28
In choosing aminosalicylate monotherapy as the treatment for older patients with CD and UC, providers may also be making an active choice to avoid immunosuppressing therapies such as immunomodulators or biologics. In our analyses, patients above 65 years with CD were significantly less likely to utilize anti-TNF monotherapy when compared with all other age groups. In a recent systematic review and meta-analysis, older-onset patients with both CD and UC were significantly less likely to utilize immunomodulators or biologics when compared with younger-onset patients.18 Although this could potentially be a marker of a less severe disease course among patients with older-onset IBD, in the same meta-analysis, patients with older-onset UC were significantly more likely to undergo surgery when compared with younger-onset patients with UC. In an evaluation from the Sinai-Helmsley Alliance for Research Excellence (SHARE) cohort, older patients were less likely to utilize anti-TNF and thiopurine therapies, although no differences were noted in disease extent, activity, or in IBD-related surgery.29 In our analyses, the highest use of combination therapy with an anti-TNF and an immunomodulator was noted in the 30- to 49-year age group, which may also indicate a concern regarding the malignancy risk of these therapies in both the youngest and oldest age ranges in our study population.
While older patients in the TARGET-IBD cohort were less likely to use anti-TNF therapy than younger patients, the overall rate of anti-TNF use among patients with IBD above 65 years in this study was higher than several reported prior evaluations.2,24 Providers and patients may have concerns regarding the safety of biologics and immunomodulators in older patients leading to decreased utilization in comparison to other mechanisms. While these concerns are well-founded given previously published evidence of increased risk of malignancy3,6,7,30,31 and infections8,32,33 in this population, prior studies evaluating therapy patterns among individuals with older-onset IBD have noted the relative paucity of high-quality data examining outcome among older patients with IBD.29 As a real-world cohort designed in part to study both the effectiveness and safety of IBD-related therapies, future research in this population will be critical to improving our understanding regarding the true risks and benefits of therapies among older individuals with IBD and the comparative effectiveness of therapies in this population.
Though this study utilized a large, multicenter cohort with standardized data collection protocols, there are limitations. This is not an inception cohort. While treatment patterns are reflective of the current management of IBD in over 30 practices across the US, these were not necessarily the first medications used for an individual patient. Therapies were categorized based on the treatment at the time of enrollment, and prior treatment failures were not evaluated. However, we would not think that a patient previously treated with biological therapy would be likely to transition to maintenance therapy with aminosalicylates at the time of enrollment in TARGET-IBD. The case report forms and redaction strategies utilized in this cohort were constructed to gain valuable and detailed data regarding the management of an individual patient’s IBD. However, our ability to analyze comorbidities that may contribute to treatment decisions is limited. In addition, our ability to evaluate the use of more recently approved biologic and small molecule therapies for the treatment of IBD was limited in comparison to anti-TNF, immunomodulator, and aminosalicylate therapies. We also realize that there are multiple competing factors that affect treatment decisions in the management of IBD. We were unable to evaluate patient and provider factors that may have contributed to specific therapy decisions. While we were able to obtain measures of disease activity using a validated instrument of symptom reporting in a subset of patients, our assessment was limited by the low response rate (38.5%) of PRO completion at the time of the study. In addition, it is possible that certain types of colitis, namely overlap syndromes in older adults (such as segmental colitis with diverticulosis), might be more likely to receive aminosalicylate therapy. We used strict diagnostic criteria for CD and UC, but we recognize this potential limitation. Finally, we did not evaluate provider-level data, including which provider prescribing patterns or provider-specific characteristics such as training, experience, or age.
In conclusion, among a large cohort from 34 academic and community centers across the United States, we demonstrated an increased use of aminosalicylates among older patients with CD and UC when compared with younger patient groups. Recent literature has demonstrated that prior beliefs of a milder disease course among older patients may not be justified, and it will be critical to assess outcomes related to these therapy choices in longitudinal analyses. Future efforts should focus on balancing safety and efficacy in the treatment of older patients with IBD, and the potential gaps that novel mechanisms of action may fill. Large, multicenter cohorts such as TARGET-IBD are well-positioned to begin to answer these questions of real-world effectiveness and safety in the near future.
ACKNOWLEDGMENTS
The authors thank the study staff, nurses, health care providers, and participants at each study center for their contributions to this work.
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