Clinical Therapeutics/Volume 32, Number 2, 2010

Self-Reported Frequency and Severity of Disease Flares,

Disease Perception, and Flare Treatments in Patients With
Ulcerative Colitis: Results of a National Internet-Based Survey
Susan C. Bolge, PhD1*; Heidi Waters, MS, MBA2; and Catherine Tak Piech, MBA2
1Consumer

Health Sciences/KantarHealth, Princeton, New Jersey; and 2Centocor Ortho Biotech Services,
LLC, Horsham, Pennsylvania

Abstract
Objectives: The purpose of this study was to better
understand the characteristics and patterns of treatment of flares of ulcerative colitis (UC) from the patients perspective. A secondary objective was to determine the predictive value of disease characteristics,
particularly disease flares, on current use of biologic
therapy.
Methods: Study participants were recruited from
an Internet panel of self-identified individuals with
inflammatory bowel disease (UC or Crohns disease).
The present analysis was limited to individuals who reported having a diagnosis of UC, were aged 18 years,
resided in the United States, and could speak and
write English. Cross-sectional data (demographic
characteristics, insurance coverage, incidence of flares,
patient experiences, treatment patterns) were collected
via a self-reported Internet-based questionnaire during the third quarter of 2008.
Results: A total of 505 individuals with UC
completed the survey (72.7% female; 16.6% nonwhite; 37.2% college graduates; mean [SD] age, 48.6
[2.8] years). The mean time since the diagnosis of UC
was 11.9 (10.1) years, and 76.6% of respondents characterized their disease as controlled. Overall, 27.9% of
the sample reported 1 flare per week, and an additional 25.1% reported 1 flare per month. Most disease flares (76.5%) lasted 7 days and were classified
as moderate in severity (51.9%). Among those reporting 1 flare per week, 30.5% classified their overall
disease severity as mild, 56.0% as moderate, and 13.5%
as severe. The majority of respondents with 1 flare per
week currently used 5-aminosalicylic acids (5-ASAs)
(41.1%) or corticosteroids (49.6%), whereas 19.1%
used immunomodulators and 17.0% used biologics.
Disease flares were most commonly treated by increasing the dose of the current medication (60.4%) or adding a corticosteroid to the treatment regimen (34.5%).
238

Conclusions: More than half of these individuals

with UC reported experiencing disease flares 1 time
per week or month. The majority reported using
5-ASAs or corticosteroids as maintenance medications
and increasing the dose or adding corticosteroids to
control flares in the short term. (Clin Ther. 2010;
32:238245) 2010 Excerpta Medica Inc.
Key words: ulcerative colitis, disease flares, frequency, overall disease severity.

Introduction
Ulcerative colitis (UC) is a chronic inflammatory
bowel disorder characterized by inflammation and
ulceration of the mucosa of the rectum and colon.1
The etiology of UC has not yet been established; however, both genetic and environmental factors have
been reported to contribute to susceptibility to inflammatory bowel disease (IBD).2,3 An ongoing epidemiologic study in Olmsted County, Minnesota, estimated
the incidence of UC to be 8.8 per 100,000 persons in
19902000 and the prevalence of UC to be 213.9 per
100,000 persons in 2001.4 However, these estimates
cannot be applied universally, as incidence and prevalence estimates of UC vary widely across populations
and geographic areas.2,5 The more developed countries of western and northern Europe and North
America have a greater incidence and prevalence of
UC than do less developed countries, although rates
have stabilized in the former and continue to rise in
the latter.2,5 Although UC can affect people of any age,
it generally follows a bimodal age distribution, with a
*Current affiliation: Centocor Ortho Biotech Services, LLC, Horsham,
Pennsylvania.
Accepted for publication January 7, 2010.
doi:10.1016/j.clinthera.2010.02.010
0149-2918/$ - see front matter
2010 Excerpta Medica Inc. All rights reserved.

Volume 32 Number 2

S.C. Bolge et al.

peak incidence in the third decade of life and a second
peak in the sixth or seventh decade.6
According to the American College of Gastroenterology (ACG), the goals of treatment for UC are to control active disease symptoms and maintain symptom
remission.7 The ACG describes use of a sequential
step-up approach in which more potent treatments
are used when less potent treatments fail.3,7,8 First-tier
treatment consists of 5-aminosalicylic acids (5-ASAs).3,9
When first-tier treatments fail to maintain symptom
remission and a disease flare occurs, corticosteroids
are used in combination with topical therapy for
symptomatic treatment.7 Because corticosteroids are
effective in inducing remission but not in maintaining
it,7 they have been considered the treatment of choice
for disease flares.3,9 A population-based study found
that within 1 year after initial treatment with corticosteroids, approximately half of those with UC were
either corticosteroid dependent or had undergone surgery.10 Moreover, treatment with corticosteroids can
lead to numerous serious adverse effects, including hypertension, diabetes, avascular necrosis, osteoporosis,
infection, impaired wound healing, and psychiatric
disturbances.1114
Immunomodulators such as azathioprine and
6-mercaptopurine are used as second-tier treatment to
maintain remission when 5-ASAs fail.3 Cyclosporine
has been reported to be effective in treating patients
hospitalized for severe UC; those who have not responded to 7 to 10 days of intravenous corticosteroid
therapy may be switched to a cyclosporine regimen.
Third-tier treatment consists of infliximab, a biologic
therapy that is the newest treatment option for patients
with UC.8 Other biologic therapies for UC are in development but have not yet received regulatory approval.8
Infliximab is approved in the United States for reducing
the signs and symptoms of UC, as well as for inducing and maintaining remission,15,16 and has been reported to decrease the need for urgent colectomy among
corticosteroid-refractory patients.17 However, the longterm colectomy risk was reported to be comparable in
patients treated with infliximab and those who were
corticosteroid responsive (18% and 11%, respectively;
odds ratio = 1.9; 95% CI, 0.2614.5), and elective
colectomy rates were found to approach 30%.17
Research has found differences between patients
perceptions of UC disease characteristics and those of
health care providers and researchers. In a recent survey, 450 respondents with UC reported a mean of
February 2010

8 self-defined disease flares per year, substantially more

than the 3 flares per year assumed by the 300 gastroenterologists surveyed in a separate arm of the study.18
In addition, fewer than half of respondents believed
that remission could mean living without disease
symptoms. In a study that sought to identify symptom
domains of UC flares that occur frequently and are
responsive to therapy, focus groups of patients with
UC identified several symptom domains that do not
appear in common indices: stool mucus, tenesmus,
difficulty distinguishing liquid or gas from solid stool
before evacuation, rapid postprandial bowel movements, loud bowel sounds, flatulence, and fatigue.19
The purpose of the present study was to gain a better understanding of the characteristics of UC disease
flares from the patients perspective. The study examined associations between the frequency of disease
flares and the perceived overall severity of UC, disease
characteristics, flare characteristics, and treatment of
flares. A secondary objective was to determine the
predictive value of self-reported disease characteristics, particularly disease flares, on the current use of
biologic therapy.

Materials and Methods

Study Design
Data for the original IBD Study and this analysis of
the subset of patients with UC were collected using a
self-reported, Internet-based questionnaire. Invitations
to participate, including a link to the 30-minute survey,
were e-mailed to individuals identified from the 2007
National Health and Wellness Survey (NHWS), an annual cross-sectional study of health care attitudes, behaviors, disease status, and outcomes in US adults aged
18 years, and an Internet consumer panel (Lightspeed
Research [LSR] Ailment Panel). Patients eligible for the
IBD Study had a diagnosis of UC and/or Crohns disease,
were aged 18 years, resided in the United States, could
speak and write English, and agreed to participate. The
analyses reported in the present paper comprise the subset of patients in the IBD Study who reported having a
diagnosis of UC without a diagnosis of Crohns disease.
Study participants received incentives for participation
in the form of points that could be accumulated and redeemed for consumer products through LSR.
The IBD Study protocol and questionnaire were
reviewed and approved by the Essex Institutional Review Board, Lebanon, New Jersey. Informed consent
was obtained before any respondent entered the sur239

Clinical Therapeutics
vey. Participation in the study was voluntary, and all
identifying information was kept confidential. Data
files included no identifying information other than a
respondent identification number.

Respondents provided detailed information about

their experience with UC in general and disease flares
in particular. Disease flares were described in the
questionnaire as a period of time during which your
symptoms worsen. Disease characteristics included
the number of years since the diagnosis of UC, overall
disease severity (classified by the patient as mild, moderate, or severe), whether the patient considered his/
her disease controlled, and whether the patient considered his/her disease bothersome. Details of disease
flares included frequency in the past year, the respondents perception of the severity of a typical flare, and
duration of a typical flare.

these, 4 (0.1%) were aged <18 years and 3448 (77.4%)

had not been diagnosed with UC or Crohns disease
by a physician and were therefore excluded. The resulting sample for the IBD Study was 1005, of whom
505 met the criteria for inclusion in the UC sample.
The UC sample had a mean (SD) age of 48.6 (2.8) years;
72.7% were female, 16.6% nonwhite, and 37.2% college graduates.
The mean time since the diagnosis of UC was 11.9
(10.1) years, and 76.6% of respondents characterized
their disease as controlled (Table I). When asked about
the number of flares experienced in the past year,
87 participants (17.2%) reported having no disease
flares, 62 (12.3%) reported 1 or 2 disease flares, 88
(17.4%) reported 3 to 6 flares, 127 (25.1%) reported
1 flare per month, and 141 (27.9%) reported 1 flare
per week. The severity of flares was characterized as
moderate by 51.9% of the sample, mild by 27.4%,
and severe by 20.7%. Most flares (49.3%) lasted 1 to
3 days, and the majority (76.5%) lasted 7 days.

Treatment Patterns

Disease Characteristics

Respondents reported their typical approach to the

treatment of flares, including increasing the dosage of
the current treatment, adding another medication class
to the current regimen, or switching to another class of
medication. Details about treatment of disease flares
with corticosteroids were also captured, including the
proportion of flares managed with corticosteroids, the
number of courses of corticosteroids used in the past
year, and whether respondents had ever stockpiled corticosteroids for future flares. In addition, respondents reported current treatment with corticosteroids, 5-ASAs,
immunomodulators, and biologics.

Disease characteristics by frequency of flares are

presented in Table I. Participants reporting more frequent flares had been diagnosed with UC for shorter
periods compared with those with less frequent flares
(9.6 years in those with 1 flare per week vs 16.0 years
in those with no flares; P < 0.001). Those with more
frequent flares were also less likely than those with
less frequent flares to characterize their overall disease
severity as mild (30.5% of those with 1 flare per
week vs 92.0% of those with no flares in the past
year; P < 0.001) or to perceive their UC as controlled
(55.3% vs 98.9%, respectively; P < 0.001). In addition, those with more frequent flares were more likely
to report that their disease was very or extremely
bothersome (41.0% vs 7.1%; P < 0.001).
A significant correlation was found between the
frequency and severity of disease flares (Pearson correlation = 0.203; P < 0.001). Participants with more
frequent flares were less likely to classify their flares
as mild compared with all other frequency groups.
Among those with 1 to 2 flares in the past year, 50.0%
classified their flares as mild, compared with 19.1%
of those with 1 flare per week (P < 0.001) (Table I).
Although the duration of flares was significantly associated with the frequency of flares when analyzed
using the 2 test (P < 0.001), this result may be slightly
misleading, in that there was no linear relationship

Study Measures
Disease Characteristics

Statistical Analysis
Descriptive analyses were performed to compare disease and flare characteristics, as well as flare treatment
patterns, across categories of disease flare frequency. The
2 test was used to test for significant differences in categorical variables, and ANOVA was used to test for significant differences in continuous variables. Pearson correlation coefficients were calculated to quantify the relation
between the frequency and severity of disease flares.

Results
Sample Characteristics
Of the initial 12,047 individuals invited to participate in the survey, 4457 agreed to participate. Of
240

Volume 32 Number 2

S.C. Bolge et al.

Table I. Ulcerative colitis (UC) characteristics as reported by the study sample.*

No. of Flares in Past Year

Total
Variable
(N = 505)
No. of years since
diagnosis, mean (SD)

None
(n = 87
[17.2%])

12
(n = 62
[12.3%])

36
1 per Mo 1 per Wk
(n = 88
(n = 127
(n = 141
[17.4%])
[25.1%])
[27.9%])

11.9 (10.1) 16.0 (12.3) 12.5 (10.5) 11.8 (9.9) 11.6 (9.8)

9.6 (7.9)

P
<0.001

Severity of UC, %
Mild
55.4
92.0
79.0
60.2
43.3
30.5
Moderate
37.8
5.7
21.0
33.0
51.2
56.0
Severe
6.7
2.3
0
6.8
5.5
13.5

<0.001

Disease controlled, %

55.3

<0.001

Bothersomeness rating, %
Not at all bothersome
15.2
50.6
19.4
8.0
6.3
4.3
Somewhat bothersome
38.5
34.1
56.5
46.6
41.7
25.2
Bothersome
23.8
8.2
14.5
27.3
29.9
29.5
Very bothersome
15.0
5.9
9.7
12.5
16.5
23.0
Extremely bothersome
7.6
1.2
0
5.7
5.5
18.0

<0.001

Severity of flares, %
40.0
Mild
27.4
50.0
23.9
20.5
19.1
Moderate
51.9
45.3
40.3
51.1
59.8
53.9
Severe
20.7
14.7
9.7
25.0
19.7
27.0

<0.001

Typical length of flares, %

13 d
49.3
50.7
53.2
44.3
59.8
40.4
47 d
27.2
13.3
25.8
33.0
24.4
34.0
810 d
8.9
8.0
3.2
6.8
9.4
12.8
1114 d
4.1
10.7
1.6
4.5
3.1
2.1
1520 d
3.2
2.7
4.8
5.7
1.6
2.8
>20 d
7.3
14.7
11.3
5.7
1.6
7.8

0.001

76.6

98.9

91.9

86.4

70.9

*Percentages within categories may not total 100 due to rounding.

between these variables as assessed using a Spearman

correlation (0.04).

Treatment Patterns
Treatment patterns by the frequency of flares are
presented in Table II. Overall, the most common
maintenance treatment was 5-ASAs (41.8%), followed
by corticosteroids (33.7%); rates of use were much
lower for immunomodulators (13.1%) and biologics
(10.1%). Current corticosteroid use was significantly
higher among respondents with more frequent disease
flares (P < 0.001). Among those experiencing 1 disease flare per week, 49.6% were currently using corFebruary 2010

ticosteroids, compared with 8.0% of those who experienced no flares in the past year. Current use of
biologics was significantly associated with the frequency of disease flares at the bivariate level (P =
0.018). Among those with no flares in the past year,
4.6% were currently using biologics, compared with
17.0% of those who experienced 1 flare per week.
The most commonly reported treatment for disease
flares was increasing the dose of the current medication (60.4%) (Table II). However, 34.5% of respondents reported adding a corticosteroid. The percentage of flares treated with corticosteroids decreased as
the frequency of flares increased (P < 0.001), suggest241

Clinical Therapeutics

Table II.Patterns of ulcerative colitis treatment, as reported by the study sample. All values are percent of
patients.

No. of Flares in Past Year

None
12
36
1 per Mo 1 per Wk

Total
(n = 87 (n = 62 (n = 88 (n = 127
(n = 141
Variable
(N = 505) [17.2%]) [12.3%]) [17.4%]) [25.1%])
[27.9%])
Current treatment*
5-ASA
41.8
42.5
48.4
48.9
33.9
41.1
Corticosteroid
33.7
8.0
27.4
23.9
43.3
49.6
Immunomodulator
13.1
10.3
8.1
12.5
11.0
19.1
Biologic
10.1
4.6
8.1
10.2
7.1
17.0
Not answered/not
receiving treatment
31.7
49.4
30.7
28.4
32.3
22.7
Typical treatment for flares*
Increase dose of current
treatment
60.4
33.3
30.6
47.7
33.9
46.8
Add 5-ASA
8.1
2.7
9.7
10.2
8.7
8.5
Add corticosteroid
34.5
33.3
32.3
28.4
40.2
34.8
Add immunomodulator
3.4
1.3
0
2.3
2.4
7.8
4.8
6.8
5.5
3.5
Add biologic
4.5
1.3
Other
24.5
36.0
33.9
17.0
23.6
19.9
Proportion of flares managed
with corticosteroids
0%
47.8

67.7
53.4
45.7
37.6
1%25%
18.7

9.7
23.9
17.3
20.6
26%50%
16.7

1.6
6.8
26.0
21.3
51%75%
8.9

4.8
3.4
7.9
14.9
76%100%
7.9

16.1
12.5
3.1
5.7
No. of courses of
corticosteroids in past year
0
4.6

10.0
2.4
2.9
5.7
12
36.7

65.0
56.1
33.3
23.9
34
29.8

15.0
24.4
31.9
34.1
57
15.6

0
7.3
21.7
18.2
810
5.5

0
7.3
7.2
4.5
11
7.8

10.0
2.4
2.9
13.6
Ever stockpiled corticosteroids
for future flares

54.1

60.0

43.9

50.7

60.2

P
0.181
<0.001
0.135
0.018
0.001

0.032
0.434
0.488
0.017
0.479
0.013
<0.001

0.003

0.302

5-ASA = 5-aminosalicylic acid.

*Respondents could select >1 treatment option.

ing some sensitivity to clinical advice against the repeated use of corticosteroids. Nonetheless, 58.7% of
respondents reported using 3 courses of corticosteroids in the past year, and 54.1% reported stockpiling
corticosteroids for future flares.
242

Discussion
The results of the present study are consistent with
previous research suggesting that patients with UC
report frequent disease flares and that a substantial
proportion of patients experience frequent disease
Volume 32 Number 2

S.C. Bolge et al.

flares.18 Overall, 17.2% of respondents to the survey
reported having no disease flares in the past year,
whereas 25.1% reported having disease flares at least
once a month and an additional 27.9% reported having flares at least once a week. Respondents with the
most frequent flares reported the greatest severity of
flares. Of those with 1 flare per month, 79.5% reported the severity of flares to be moderate to severe,
compared with 80.9% of those with 1 flare per week.
Most flares lasted from 1 to 7 days (84.2% of those
with 1 flare per month; 74.4% of those with 1 flare
per week). With frequent disease flares occurring in
such a substantial proportion of patients with UC, it
is not surprising that an informal survey identified
unanticipated flares as one of the 8 most common
fears among patients with IBD.20
There appear to be a number of discrepancies between patients and physicians perceptions and experiences of disease control. In the survey results reported by Rubin et al,18 physicians underestimated
the frequency of disease flares as reported by patients.
There may be a variety of reasons for the discrepancy
between patient and physician perceptions. While
conducting focus groups of patients with UC, Joyce et
al19 found that patients identified several symptom
domains of disease flares that are not generally recognized in common disease indices. These unrecognized
symptoms may reduce the likelihood of physicians
identifying disease flares in the way that patients do
and suggest that patients and physicians define flares
differently.
The results of this study suggest the existence of
additional discrepancies between patients experience
of disease flares and their perception of disease control. Although 76.6% of patients in this study reported that their UC was controlled, 70.5% reported
having 3 disease flares in the past year. It is difficult
to reconcile these data, and more research is needed
to clarify these findings. Some participants may have
identified less bothersome symptoms as disease flares,
or others may have considered such symptoms manageable and thus that their UC was controlled. The
discrepancy suggests that patients may not recognize
that disease flares indicate a lack of disease control,
but believe that symptoms are an expected part of UC.
The findings of this study and those by Rubin et al18
and Joyce et al19 suggest that if clinicians underestimate the frequency of flares among their patients, the
patients may be less likely to contact them and express
February 2010

a need for more effective treatment. In addition, Rubin et al found that patients do not consider remission
of UC to mean living without disease symptoms,
which may indicate their accommodation or resignation to having some level of symptoms, even in cases
of controlled disease. Although the present study
did not examine patientclinician communication, the
evidence suggests an unmet need for patient education
programs and other tools to help patients and physicians communicate effectively about the frequency and
symptoms of disease flares.
The ACG recommendations for the treatment of
UC typically involve a step-up approach, beginning
with 5-ASAs and progressing next to immunomodulators and then to biologics.7 As earlier treatments on
this continuum fail, corticosteroids are introduced to
treat disease flares, and more powerful treatments are
added to maintain remission.3,79 However, the results
of the present study suggest that when the frequency
of flares exceeds once a month, use of corticosteroids
is more common than use of 5-ASAs. Because biologics are approved for use in moderate to severe UC, the
higher use of biologics in patients with the highest
frequency of flares is not unexpected, although overall
rates of biologic use among those with frequent flares
remains low. Although further research is necessary to
determine why biologics are not more widely used,
there are 2 possible explanations. Infliximab is a relatively recent entry into the treatment paradigm for
UC, and it often takes time for a new therapy to be
integrated into standard practice. The most recent ACG
treatment guidelines recommend the use of infliximab
in patients with mild to moderate active disease and
those with severe UC.7 Before publication of these
guidelines, infliximab may have been used primarily
in patients with severe disease, as a last therapeutic
option before colectomy. The updated guidelines may
alter the treatment paradigm to allow use of infliximab earlier and in more moderate forms of disease.
However, the present study did not examine the effectiveness of therapy or how long a patient was receiving a particular treatment.
When patients present with frequent flares of UC,
physicians make treatment decisions based on a number of factors, including disease history, endoscopic or
laboratory findings, and their own management preferences. However, failure of earlier treatments on the
continuum (eg, first-line treatment with corticosteroids has been associated with a 50% remission rate
243

Clinical Therapeutics
in patients with severe UC21) and lack of evidence that
the current step-up approach alters the natural history
of UC have led some investigators to consider earlier
intervention with immunomodulators and biologics.8,22
Future research should consider the possible need for
more aggressive maintenance treatment paradigms
and the potential effects of such paradigms on patients perceptions of disease flares.
This study found that the percentage of flares treated
with corticosteroids decreased as the frequency of
flares increased, which was attributed to the clinical
practice of avoiding repeated corticosteroid use. However, it is also possible that patients with the greatest
number of flares may not be receiving adequate treatment, that their flares are not being reported to their
physicians, or that their flares are not actually UC but
symptoms of another condition (eg, IBD).
An unexpected and interesting finding was that
54.1% of respondents reported stockpiling corticosteroids for future flares, regardless of the frequency
of their flares. Overall, the study sample had managed
UC for >11 years. Their stockpiling behavior may
have been based on accumulated experiences over
time and not just in the year addressed by the study.
For example, they might have found it difficult to see
their physician or fill a prescription quickly during a
flare and thus feel comfortable knowing that they
have treatment readily available.
This was a cross-sectional, patient-reported, and
Internet-based study. There are limitations inherent to
this study design. First, the cross-sectional nature of
the study does not allow for inferences concerning
causation; rather, the results can be interpreted only
as associations between disease flares and disease and
treatment characteristics. Second, all data were selfreported, and there was no clinical confirmation or
examination of patient records. It is possible that participants overestimated or underestimated the frequency
of flares, or incorrectly reported UC symptoms. Finally,
the sample may not be representative of individuals
who do not have Internet access. However, according
to data from the US Census Bureau, ~70% of adults
in the United States had Internet access in 2006, with
higher rates among younger adults,23 who are more
likely to have UC.6

CONCLUSIONS
In this Internet survey of individuals with UC, more
than half reported experiencing disease flares 1 time
244

per week or month. The majority reported using 5-ASAs

or corticosteroids as maintenance medications and
increasing the dose or adding corticosteroids to control flares in the short term. More than half reported
stockpiling corticosteroids for future flares. Further
research is needed to determine whether better patient
clinician communication about disease flares and more
aggressive maintenance treatment paradigms may
help promote better disease control among patients
who continue to experience frequent disease flares.

Acknowledgments
Centocor Ortho Biotech Services, LLC, Horsham,
Pennsylvania, licensed access to the NHWS and funded the analysis and preparation of this paper. The
NHWS and IBD Study were conducted by Consumer
Health Sciences/KantarHealth, Princeton, New Jersey.
The authors are employees of Centocor Ortho Biotech Services. They have indicated that they have no
other conflicts of interest with regard to the content of
this article.
The authors thank Deborah Freedman, MBA, of
Consumer Health Sciences/KantarHealth, and Fanta
Waterman Purayidathil, MPH, who was an employee
of Consumer Health Sciences/KantarHealth at the
time of the study, for assistance in designing and managing the study.

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Address correspondence to: Susan C. Bolge, PhD, c/o Marco daCosta

DiBonaventura, PhD, Manager, Health Economics and Outcomes
Research, KantarHealth, 825 Third Avenue, New York, NY 10022.
E-mail: marco.dibonaventura@kantarhealth.com
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