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Ethos V2

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Transcript of Ethos V2

THERAPEUTIC

DRUG MONITORING

PERSONALIZED
MEDICINE

PROACTIVE TREATMENT IN
CROHN'S DISEASE

Establishing treatment goals, regularly assessing progress towards those goal, and making adjustments to therapy to reach those goals.
TREAT
TO TARGET

Diabetes
Cardiovascular Disease
Rheumatoid Arthritis
Crohn’s Disease
Minimize
patient suffering
and
prevent long-term

damage

to the GI tract.

Treatment Guidlines
Publication Placeholder
Maintenance of symptom control
Improvement in quality of life
Minimization of short- and long-term toxicity
Mucosal
Healing
Patients in clinical remission may continue to have ongoing inflammation, which can lead to progressive bowel damage
Mucosal healing is increasingly recognized as a treatment goal
.
Deep remission” is associated with fewer flares, lower surgery rates, and fewer hospitalizations among CD patients.
International Organization for the Study of Inflammatory Bowel Diseases

Clinical

Endoscopic

Histologic

Imaging

Biomarker

Patient-reported outcomes
Abdominal pain

Normalization
of bowel habits

Mucosal healing
3 Months
6-12 Months
Patients should be assessed
until symptoms resolve
thereafter
Optimize Therapy
Drug and Anti-Drug Antibody Levels
1
Detectable levels of drug are present
2
Minimal to no detectable anti-drug antibodies
3
Monitoring the level of drug
THE GOAL
based upon information about a patient’s
Modify the dose
Switch to another agent
or
either within the same class or to a new mechanism of action
Therapeutic drug monitoring may
Improve outcomes
Minimize adverse events
Improve quality of life
Scenarios Included In Algorithm
1
Patients who have detectable anti-drug antibody levels
2
Patients with a therapeutic anti-TNF concentration
3
Patients with sub-therapeutic anti-TNF levels
Patient Type Algorithm Recommendations
Switching to another anti-TNF agent. If symptoms persist, it recommends you consider an agent with another mechanism of action.
Switching to another mechanism of action.
To increase the dose or frequency of dosing
To increase the dose or frequency of dosing
Switch to another anti-TNF agent. If symptoms persist, it asks that you consider an agent with another mechanism of action
Anti-drug antibodies
Therapeutic anti-TNF drug levels
Sub-therapeutic anti-TNF drug levels
Sub-therapeutic anti-TNF drug levels
Disease Relapse With
Reactive Vs
Patients With Disease Relapse, %
Proactive Dose Adjustments
Reactive Dosing (n=21/123)
Proactive Dosing (n=9/128)
17
7
P=0.018
*Disease relapse: need for dose escalation, addition of steroids, or switch to another antiinflammatory agent; †Proactive dosing: trough concentrations and ADA levels were used to guide changes in dose and dosing frequency to attain a target trough concentration of 3-7 µg/mL
Treating-To-Target
Challenges
The dearth of prospective studies and lack of established guidelines


Turnaround time required for testing and need for an additional office visit to review results and make any appropriate modifications to therapy


Insurance coverage and reimbursement policies are variable, which may result in the assays being cost-prohibitive

One aspect of personalized medicine involves knowledge of factors that may predict prognosis and therefore guide treatment approach.
Another aspect is to identify and address barriers that can keep patients from optimal care. These factors include...
Adherence
Access to medications
Patient’s emotional well-being
Several factors that have been found to correlate with poor prognosis in Crohn’s disease
Demographic factors

Smoking

Diagnosis under age 40

Need for steroid treatment at diagnosis

Certain disease characteristics are also predictors
Perianal disease

Extensive ileal or colonic disease

Extra-intestinal manifestations

Serologic markers of poor prognosis include ASCA, anti-OmpC, and CBir1

Markers of inflammation like CRP, ESR and fecal calprotectin may predict increased severity of disease.


Adherence
, especially in the context of a chronic disease like CD, is often a challenge.
Non-Adherence
35%
72%
Adherence
About
their disease
and the
consequences of insufficiently controlled disease
and to set the expectation that they will
require life-long therapy
to manage their disease.
Important to
educate patients
The Crohn’s and Colitis Foundation of America (CCFA)

CrohnsandColitis.com

The National Institutes of Diabetes and Digestive and Kidney Disease.
Educational Resources
Reminder Resources for Medicines As Prescribed
Medication reminder tools and smart phone applications
Support programs provided by pharmaceutical companies
Adherence,
is also affected by a patient’s ability to access and pay for their medications.
Many pharmaceutical companies offer patient
support services
that
investigate
a patient’s
benefits
and
navigate
the
process of obtaining their medication.

Financial assistance with out-of-pocket expenses
are a frequent component of these patient support services

Some treatment options can be administered in the office rather than by the patient at home,
which helps the physician to monitor and support patient adherence.
Activity and exercise
Helps to improve
physical health, life satisfaction, cognitive functioning
, and
psychological
well-being.

Anxiety
Depression
Emotional
Wellbeing
Adherence
Patients with Crohn's Disease
5x more likely
More frequent and earlier relapses.
50%
made
10 or more calls
to their
IBD providers each month.
More frequent e
mergency department visits and hospital admissions.
Inflammatory Bowel Disease Support Foundation (IBDSF)

CCFA

Local area chapters
Some patients may benefit from referral to a
psychiatrist or psychologist.
Sara's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
6-8 per day
Moderate-to-severe levels of pain on a daily basis
Moderate-to-severe disease with ulcers in the ileum and right colon; no perianal disease
Elevated CRP of 30 mg/L
Sara's Living Situations
Recently Married
Starting a family in the next 1-2 years
Concerns
Crohn's Disease treatments during pregnancy.
Impact
Often cannot do the activities that she used to do. She says that she used to be very active, but worries that she will not be able to get to a bathroom in time.
Treatment Goals
Reduce the number of trips to bathroom each day.
Wants to be aware of the risks that her treatments might carry should she become pregnant.
CIMZIA
CIMZIA® (certolizumab pegol) is an anti-TNF agent indicated for adult patients with moderate-to-severe CD with an inadequate response to conventional therapies.
Pre-filled syringe for self-injection
Lyophilized formulation for in-office administration
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
69%
40%
Clinical Response at Week 26 for Patients with no TNFi Experience
n=159
n=163
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Remission at Week 26 (overall)
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Potential Risks of Therapy During Pregnancy
Low transfer of CIMZIA across the placenta to the infants
1
2
3
4
5
6
7
8
9
10
No fetal harm was observed in animal reproduction studies
CIMZIA should only be used during pregnancy if it is clearly needed
Pregnancy Exposure Registry
It is not currently known whether
CIMZIA
is excreted in human milk.
Case Manager
Investigate
Benefits
Help
Navigate
97%
Financial Assistance
$0 COPAY
Mike's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
3-4 per day , sometimes with blood
Mild-to-moderate levels of pain almost every day
Indicates diffuse ileitis
Elevated CRP of 15 mg/L with maximal therapeutic levels of 6-TGN.
Mike's Living Situations
Construction Worker
Married
3 children ranging from 6 to 12 years old.
Concerns
Worried that his disease will negatively impact his career, which will hurt his family.
Impact
Makes doing his job difficult
Treatment Goals
Reduce the urgency and number of trips to the bathroom each day
Enjoy spending time with his family
CIMZIA
CIMZIA® (certolizumab pegol) is an anti-TNF agent indicated for adult patients with moderate-to-severe CD with an inadequate response to conventional therapies.
Pre-filled syringe for self-injection
Lyophilized formulation for in-office administration
Pre-Filled Syringe

=
The best option for Mike as he’s frequently on the go for work.
63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
69%
40%
Clinical Response at Week 26 for Patients with no TNFi Experience
n=159
n=163
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Remission at Week 26 (overall)
n=210
n=215
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
29%
48%
Difficult to keep up with his children
Keep his disease from getting worse.
n=210
n=215
P<0.001
29%
48%
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
IBDQ Response at Week 26
n=210
n=214
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Quality of Life
43%
60%
IBDQ Response: Increase of ≥16 points in IBDQ score
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Disease Progression at Week 26

n=xxx
n=xxx
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Disease Progression
53%
14%
IBDQ Response: Increase of ≥16 points in IBDQ score
CIMZIA®
(certolizumab pegol) was associated with a significantly reduced rate of disease progression than placebo at Week 26
Disease Progression
CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Right Start Nurse Program
Jack's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
5-6 liquid stools per day.
Moderate levels of pain on a daily basis.
Non-ulcerative lesions in the sigmoid and left colon and both superficial and deep ulcerations in the transverse colon.
Normal CRP, but his calprotectin is elevated.
Mike's Living Situations
Recently graduated from college
Currently working at an accounting firm
Single
Concerns
Needing to use the restroom while out.

At his new job he sits a distance from the office bathroom, which is in a public area
Impact
Often feels isolated from his friends
Treatment Goals
Reduce the number of trips to bathroom each day so that he can feel more comfortable going out and being social.
CIMZIA
CIMZIA® (certolizumab pegol) is an anti-TNF agent indicated for adult patients with moderate-to-severe CD with an inadequate response to conventional therapies.
Pre-filled syringe for self-injection
Lyophilized formulation for in-office administration
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
69%
40%
Clinical Response at Week 26 for Patients with no TNFi Experience
n=159
n=163
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Remission at Week 26 (overall)
n=210
n=215
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
29%
48%
Embarrassed to discuss his symptoms with his friends or his roommates
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
IBDQ Response at Week 26
n=210
n=214
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Quality of Life
43%
60%
IBDQ Response: Increase of ≥16 points in IBDQ score
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Clinical Response* and Remission† at Week 26

Remission
Response
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Response and Remission in Patients Diagnosed with CD 1-2 Years Before CIMZIA Use
55%
75%
* Response defined as ≥100-point decrease in CDAI score from baseline at Week 26. Remission defined as CDAI score ≤150 points at Week 26.

CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Medication Reminders
Living on his own and his mother often needed to remind him to take his medications.

In-office administration =
Given some of the challenges that Jack shared regarding past adherence to his medications
50%
36%
Improvements in the signs and symptoms of disease.
Improvements in quality of life.
Reductions in the likelihood of disease progression.
Women who are pregnant or considering to become pregnant there are placental transfer data available.
SARA
MIKE
JACK
Age
Diagnosed
Loss of Response
26
4 yrs ago
current immunomodulator therapy
Age
Diagnosed
Loss of Response
47
10 yrs ago
immunomodulator therapy
Age
Diagnosed
Loss of Response
22
1 year and a half ago
current immunomodulator therapy
Sara's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
6-8 per day
Moderate-to-severe levels of pain on a daily basis
Moderate-to-severe disease with ulcers in the ileum and right colon; no perianal disease
Elevated CRP of 30 mg/L
Sara's Living Situations
Recently Married
Starting a family in the next 1-2 years
Starting a family in the next 1-2 years
Concerns
Crohn's Disease treatments during pregnancy.
Impact
She often cannot do the activities that she used to do. She says that she used to be very active, but worries that she will not be able to get to a bathroom in time.
Treatment Goals
Reduce the number of trips to bathroom each day.
Wants to be aware of the risks that her treatments might carry should she become pregnant.
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Potential Risks of Therapy During Pregnancy
Low transfer of CIMZIA across the placenta to the infants
1
2
3
4
5
6
7
8
9
10
No fetal harm was observed in animal reproduction studies
CIMZIA should only be used during pregnancy if it is clearly needed
Pregnancy Exposure Registry
It is not currently known whether
CIMZIA
is excreted in human milk.
Case Manager
Investigate
Benefits
Help
Navigate
97%
Financial Assistance
$0 COPAY
SARA
Age
Diagnosed
Loss of Response
26
4 yrs ago
current immunomodulator therapy
Mike's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
3-4 per day , sometimes with blood
Mild-to-moderate levels of pain almost every day
Indicates diffuse ileitis
Elevated CRP of 15 mg/L with maximal therapeutic levels of 6-TGN.
Mike's Living Situations
Construction Worker
Married
3 children ranging from 6 to 12 years old.
Concerns
Worried that his disease will negatively impact his career, which will hurt his family.
Impact
Makes doing his job difficult
Treatment Goals
Reduce the urgency and number of trips to the bathroom each day
Enjoy spending time with his family
Pre-Filled Syringe

=
The best option for Mike as he’s frequently on the go for work.
Difficult to keep up with his children
Keep his disease from getting worse.
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
IBDQ Response at Week 26
n=210
n=214
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Quality of Life
43%
60%
IBDQ Response: Increase of ≥16 points in IBDQ score
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Disease Progression at Week 26

n=xxx
n=xxx
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Disease Progression
53%
14%
IBDQ Response: Increase of ≥16 points in IBDQ score
CIMZIA®
(certolizumab pegol) was associated with a significantly reduced rate of disease progression than placebo at Week 26
Disease Progression
CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Right Start Nurse Program
MIKE
Age
Diagnosed
Loss of Response
47
10 yrs ago
immunomodulator therapy
Jack's Clinical Symptoms
Liquid Stools:
Pain:
Colonoscopy:
Laboratory Assessments:
5-6 liquid stools per day.
Moderate levels of pain on a daily basis.
Non-ulcerative lesions in the sigmoid and left colon and both superficial and deep ulcerations in the transverse colon.
Normal CRP, but his calprotectin is elevated.
Mike's Living Situations
Recently graduated from college
Currently working at an accounting firm
Single
Concerns
Needing to use the restroom while out.

At his new job he sits a distance from the office bathroom, which is in a public area
Impact
Often feels isolated from his friends
Treatment Goals
Reduce the number of trips to bathroom each day so that he can feel more comfortable going out and being social.
CIMZIA
CIMZIA® (certolizumab pegol) is an anti-TNF agent indicated for adult patients with moderate-to-severe CD with an inadequate response to conventional therapies.
Pre-filled syringe for self-injection
Lyophilized formulation for in-office administration
In-office administration =
Given some of the challenges that Jack shared regarding past adherence to his medications
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
60%
43%
Clinical Response at Week 26 for Patients with no TNFi Experience
n=159
n=163
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Remission at Week 26 (overall)
n=210
n=215
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
29%
48%
Embarrassed to discuss his symptoms with his friends or his roommates
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
IBDQ Response at Week 26
n=210
n=214
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Quality of Life
43%
60%
IBDQ Response: Increase of ≥16 points in IBDQ score
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
Clinical Response* and Remission† at Week 26

Remission
Response
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Response and Remission in Patients Diagnosed with CD 1-2 Years Before CIMZIA Use
55%
75%
* Response defined as ≥100-point decrease in CDAI score from baseline at Week 26. Remission defined as CDAI score ≤150 points at Week 26.

CIMZIA (certolizumab pegol) is a member of the anti-TNF biologics class
. It has similar adverse effects and safety precautions that are associated with other members of the drug class.
Please keep in mind the following information when prescribing CIMZIA to patients, and
please see full prescribing information for more details.
Serious and sometimes fatal side effects have been reported with CIMZIA, including
tuberculosis (TB)
,
bacterial sepsis
,
invasive fungal infections (such as histoplasmosis)
, and infections due to other opportunistic pathogens
(such as Legionella or Listeri
a).
Patients should be
closely monitored
for the signs and symptoms of infection
during and after treatment
with CIMZIA.
Communicate Important Safety Information and Safety Concerns
Medication Reminders
Living on his own and his mother often needed to remind him to take his medications.

63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
50%
36%
JACK
Age
Diagnosed
Loss of Response
22
1 year and a half ago
current immunomodulator therapy
PROAC IVE TREATMENT IN
CROHN'S DISEASE

3 of every 5 patients with 2-5 year’s disease duration responded to CIMZIA
close to
half
were in remission at
week 26.
63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo (3 doses
CIMZIA 400 mg
at Weeks 0, 2, & 4,
then placebo q4w)
CIMZIA
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
29.1%
46.7%
vs
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