A398
V A L U E I N H E A L T H 1 4 ( 2 0 1 1 ) A 2 3 3 - A 5 1 0
remission. Significant predictors of medical costs (pϽ0.05) were disease activity,
disease history for both groups, age and employment status for CD subjects and
previous colectomy for UC subjects. CONCLUSIONS: Our analyses show that med-
ical costs of patients with IBD can in part be predicted. However, predictors differ
between CD and UC patients: Disease activity and disease history are the most
important cost predictors, while age and employment status are only important
cost predictors for CD patients.
REgistry for SynagiS (CARESS) database from infants who received Ն1 dose of
palivizumab during the 2005-2010 RSV seasons. Respiratory illness (RI) events were
documented monthly. RESULTS: The 7699 infants enrolled were premature (Յ35
completed weeks gestational age, without any underlying medical illnesses;
nϭ5237), had chronic lung disease/bronchopulmonary dysplasia (nϭ646), hemo-
dynamically significant congenital heart disease (nϭ766), or had other pre-existing
conditions such as neuromuscular impairments, Down syndrome, pulmonary or
airway malformations, immunocompromise or cystic fibrosis (nϭ1050). The over-
all RIH rate was 6.0%. Premature infants had a significantly lower rate (4.1%) than
the other groups (range 8.7% -11.5%; Bϭ-0.912, dfϭ1, pϽ0.005). The overall RSVH
rate was 1.47% with significant differences between groups (range 1.22% - 2.46%;
2ϭ22.606, dfϭ3, pϽ0.0005). Apart from hospital length of stay, morbidities differed
significantly across the sub-groups during RSVH including number of ICU admis-
sions and length of stay, number ventilated and duration of intubation, number
requiring respiratory support and duration (all pϽ0.05). CONCLUSIONS: Hospital-
ization rates for RI events and RSV illness were different across the groups. Com-
parisons with other registries indicate that RSVH rates are in the lower range over-
all (range 1.3 -8.1%); however, comparisons are difficult to establish as most studies
do not account for the varying lengths of observation that arise because infants are
enrolled at different times during the RSV season.
Individual’s Health – Clinical Outcomes Studies
PIH1
COMPARISON OF UNINTENDED PREGNANCY RATES IN USERS OF 84/7, 21/7,
AND 24/4 ORAL CONTRACEPTIVE REGIMENS
1
2
3
Brewster C , Howard B , Lage M
1
2
Teva Pharmaceuticals, Kansas City, MO, USA, Teva Branded Pharmaceutical Products R&D,
Inc., Horsham, PA, USA, HealthMetrics Outcomes Research, Groton, CT, USA
3
OBJECTIVES: To compare pregnancy rates post initiation on oral contraceptive (OC)
users of 84 days levonorgestrel/ethinyl estradiol (EE) 0.15mg/0.03mg tablets plus EE
0.01mg for 7 days in place of placebo (84/7) or, 21 days combined EE/progestin plus
7 days placebo (21/7) or 24 days EE/progestin plus 4 days placebo (24/4) over the
course of 1 year. METHODS: Data for this study were obtained from the US i3
Invision™ Data Mart and spanned the period from January 1, 2006 through March
31, 2010. Patients were included if they received the medication of interest (with
first such receipt identified as index date), were age 15-40 on index date, and had
continuous insurance coverage from index date through 1 year post index date.
Two distinct analyses were performed: 1 comparing pregnancy rates post initiation
on an 84/7 or 21/7 OC and the other comparing pregnancy post initiation on an 84/7
or 24/4 OC. The 84/7 cohort was matched to each of the alternative cohorts of
interest based upon age, sex, region, business type of insurance, insurance product,
and year of index date. RESULTS: There were 5,821 individuals in the 84/7 cohort,
650,816 individuals in the 21/7 cohort, and 111,540 individuals in the 24/4 cohort.
Matching of the 84/7 cohort to each of the alternative cohorts resulted in a success-
ful match rate of over 99% when comparing 84/7 to 21/7 or comparing 84/7 to 24/4.
Pregnancy rates in the 1 year post initiation on an OC were found to be statistically
significantly lower for initiators of 84/7 compared to 21/7 (3.04% vs. 5.12%;
PϽ0.0001) as well as when comparing 84/7 to 24/4 (3.03% vs. 5.28%; PϽ0.0001).
CONCLUSIONS: In this study, pregnancy rates were significantly lower in women
using an 84/7 OC regimen compared to 21/7 or 24/4 regimens.
PIH4
A COMPARATIVE STUDY OF RESPIRATORY SYNCYTIAL VIRUS (RSV)
PROPHYLAXIS IN PREMATURE INFANTS
1
2
2
3
Paes BA , Li A , Lanctot KL , Mitchell I
1
2
McMaster University, Hamilton, ON, Canada, Sunnybrook Health Sciences Centre, Toronto, ON,
3
Canada, University of Calgary, Calgary, AB, Canada
OBJECTIVES: Infants 33-35 completed weeks’ gestational age (GA) and those Յ 32
weeks GA incur similar rates of respiratory syncytial virus hospitalization (RSVH)
and morbidities which targets them as risk groups for RSV prophylaxis in current
international pediatric advisory statements. We examined immunization regi-
mens, compliance and outcomes of premature infants who received palivizumab
within the Canadian Registry Database (CARESS). METHODS: Neonatal and demo-
graphic data were collected from infants receiving Ն1 dose of palivizumab during
the 2006-2010 RSV seasons across 29 recruitment sites. Respiratory illness (RI)
events were captured monthly. Premature infants’ Յ32 weeks GA without pre-
existing medical disorders (Group 1) was compared to a similar moderate-high risk
group 33-35 completed weeks GA (Group 2) who received prophylaxis. RESULTS:
4819 patients were analyzed (Group 1, nϭ3746; Group 2, nϭ1073). Mean GA: 30.0Ϯ
3.1 versus 34.2Ϯ2.0. The groups were similar for proportion of Caucasians, mothers’
who smoked daily and during pregnancy, history of atopy and number of multiples
in the family. There were significant differences (Group 1, Group 2; pϽ0.005) in:
mean birth weight (g) (1445Ϯ606 versus 2142Ϯ521), proportion of males (54.3%
versus 63.1%), and number with siblings (54.2% versus 74.6%), siblings in daycare
(13.9% versus 35.0%), Ն2 household smokers (9.9% versus 14.0%) and Ն 5 individ-
uals living in the household (22.7% versus 44.0%). Group 1 had significantly more
complicated neonatal courses. Overall infants received 91.9%Ϯ30.7% of expected
number of injections. Group 1 received more injections (3.9Ϯ1.7 versus 3.5Ϯ1.6;
pϽ0.005) and had higher compliance rates (92.8% versus 88.9%; pϽ0.005). Respec-
tive RI and RSVH rates (4.5% versus 3.4%; hazard ratioϭ0.852, pϭ0.385) and (1.30%
versus 1.3%; hazard ratioϭ1.233, pϭ0.543) were similar. CONCLUSIONS: Overall
compliance with RSV prophylaxis in the premature population is high and despite
the higher number of palivizumab doses in infants Յ32 weeks GA, group RI and
RSVH rates were similar.
PIH2
CARESS: THE CANADIAN REGISTRY OF SYNAGIS (2005-2010)
1
2
3
3
Paes BA , Mitchell I , Li A , Lanctot KL
1
2
McMaster University, Hamilton, ON, Canada, University of Calgary, Calgary, AB, Canada,
Sunnybrook Health Sciences Centre, Toronto, ON, Canada
3
OBJECTIVES: To evaluate the current management of children at high-risk of RSV
infection who received palivizumab prophylaxis and were enrolled in the Canadian
Registry Database. METHODS: A prospective, observational, registry of infants who
received at least 1 dose of palivizumab during the 2005-2010 RSV seasons across 29
sites. Neonatal and demographic data were collected from the parent/caregiver at
enrollment. Data on palivizumab utilization, compliance, and outcomes related to
respiratory illness (RI) events were collected monthly. RESULTS: A total of 7699
infants were enrolled with an average age of 5.4Ϯ6.0 months. Participants were
typically male (56.2%), Caucasian (71.5%) with an average gestational age (GA) of
32.2Ϯ6.0 completed weeks. A total of 5237 (68.0%) infants received palivizumab for
prematurity (Յ35 completed weeks GA without underlying medical disorders), 646
(8.4%) had chronic lung disease, 766 (9.9%) hemodynamically significant congenital
heart disease and 1050 (13.6%) were prophylaxed for other conditions such as CNS
disorders, airway anomalies and cystic fibrosis. Patients received an average of
3.9Ϯ1.6 injections and 30,040 doses overall; 5.5% of patients withdrew from the
study. No direct, drug related serious adverse events were identified. 460 infants
had a total of 541 RI hospitalizations resulting in a hospitalization rate of 6.0%.The
overall RSV positive hospitalization (RSVH) rate was 1.47%. Living with siblings
(pϭ0.046) and having Ͼ5 individuals in the household (pϭ0.007) was significantly
associated with time to a patient’s first RSVH. Other risk factors traditionally asso-
ciated with a higher risk for RSV infection, such as gender (pϭ0.429), smoking
(pϭ0.182), daycare attendance (pϭ0.079), age (pϭ0.213), and compliance with treat-
ment (pϭ0.695) were not found to be significantly correlated. CONCLUSIONS: The
RSVH observed from 2005-2010 was 1.4% overall (range 0.3% - 2.1%) and compares
favorably with international registry data despite the steady increase in the num-
ber of Canadian immunized infants with serious underlying medical disorders.
PIH5
RESPIRATORY SYNCYTIAL VIRUS (RSV) PROPHYLAXIS IN SPECIAL
POPULATIONS
1
2
2
3
Paes BA , Li A , Lanctot KL , Mitchell I
1
2
McMaster University, Hamilton, ON, Canada, Sunnybrook Health Sciences Centre, Toronto, ON,
3
Canada, University of Calgary, Calgary, AB, Canada
OBJECTIVES: To compare palivizumab utilization and compliance in infants who
meet standard indications for RSV prophylaxis versus those with pre-existing
medical disorders within the Canadian Registry Database (CARESS). METHODS: A
prospective, observational registry of infants across 29 sites who received at least 1
dose of palivizumab during the 2006-2010 RSV seasons. Neonatal and demographic
data were collected from the parent/caregiver at enrollment. Data on palivizumab
utilization, compliance, and outcomes related to respiratory illness (RI) events
were collected monthly. Premature infants’ 35 completed weeks’ gestational age
(GA) without medical conditions who met standard approval criteria for palivi-
zumab (Group 1) were compared to infants with underlying medical illnesses
(Group 2). RESULTS: 5832 patients were analyzed (Group 1, nϭ4880; Group 2,
nϭ952). The two groups were similar in terms of gender (male: 56.4% versus 55.6%;
pϭ0.829). Group 2 infants included Down syndrome (nϭ193, 20.3%), upper airway
anomalies (nϭ178, 18.7%), pulmonary disorders (nϭ127, 13.3%), cystic fibrosis
(nϭ117, 12.3%), neuromuscular impairment (nϭ78, 8.2%), multiple system disor-
ders (nϭ57, 6.0%), cardiac disorders (nϭ22, 2.3%), immunocompromise (nϭ17,
1.8%), and miscellaneous (nϭ163, 17.1%). From 2006-2010, the proportion of Group
2 infants receiving prophylaxis increased 3.4-fold from 5.6% (69/1224) to 19.1%
(462/2413). Overall, Group 2 infants were older at enrollment (10.2 Ϯ 9.2 versus 3.5
Ϯ 3.1 months, pϽ0.005), had a significantly higher GA (35.9 Ϯ 6.0 versus 31.0 Ϯ 5.4
completed weeks, pϽ0.005) and had significantly higher RI (9.0% versus 4.2%, pϽ0.0
05) and RSV hospitalization (2.35% versus 1.32%, pϭ0.003) rates. A lower proportion
of Group 2 infants were compliant with treatment (69.4% versus 72.6%, pϭ0.048).
There were no serious adverse events directly related to palivizumab.
PIH3
RESPIRATORY SYNCYTIAL VIRUS HOSPITALIZATIONS IN THE CANADIAN
REGISTRY FOR SYNAGIS (CARESS)
1
2
2
3
Paes BA , Li A , Lanctot KL , Mitchell I
1
2
McMaster University, Hamilton, ON, Canada, Sunnybrook Health Sciences Centre, Toronto, ON,
3
Canada, University of Calgary, Calgary, AB, Canada
OBJECTIVES: Paediatric advisory committee guidelines recommend palivizumab
prophylaxis for specific sub-populations of infants at high risk for respiratory syn-
cytial virus (RSV) infection. However, effectiveness of palivizumab may vary across
indications and countries. The objective of our study was to determine hospital-
ization rates for respiratory illness (RIH) and RSV-positive infections (RSVH) follow-
ing prophylaxis and compare rates found in this study with other world-wide data
from published registries. METHODS: Neonatal and demographic data were col-
lected prospectively across 29 national sites as part of an established CAnadian
Bernhardt, Paul V.
