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Ethos V5

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Transcript of Ethos V5

JACK
Age
Diagnosed
Loss of Response
22
1 year and
a half ago

current immunomodulator therapy
MIKE
Age
Diagnosed
Loss of Response
47
10 yrs ago
current immunomodulator therapy
SARA
Diagnosed
Loss of Response
26
4 yrs ago
current immunomodulator therapy
Lyophilized formulation for in-office administration
Establishing treatment goals, regularly assessing progress towards those goals, and making adjustments to therapy to reach those goals.
Diabetes
Cardiovascular Disease
Rheumatoid Arthritis
Crohn’s Disease
Minimize
patient suffering
and
prevent long-term

damage

to the GI tract

Induction and maintenance of symptom control
Improvement in quality of life
Minimization of short- and long-term toxicity
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
(IOIBD)

Clinical

Endoscopic

Histologic

Imaging

Biomarker

Patient-reported outcomes
Abdominal pain

Normalization
of bowel habits

Mucosal healing

Address patient’s individual goals
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
Patients Stratified Into Groups
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
Switching to another anti-TNF agent.
Disease Relapse
Patients With Disease Relapse, %
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
Lack of established guidelines

Testing and review of results require additional time and office visits

Assays may not be covered
by insurance

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
Factors correlated with poor prognosis
Demographic factors

Smoking

Diagnosis under age 40

Need for steroid treatment at diagnosis

Disease characteristics predicting poor prognosis
Perianal disease

Extensive ileal or colonic disease

Extra-intestinal manifestations

Serologic markers (ASCA, anti-OmpC, CBir)

Markers of inflammation (CRP, ESR, fecal CP).

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.
Selecting a treatment that is right for her if/when she decides to start a 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
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
No fetal harm was observed in animal reproduction studies
It is not currently known whether
CIMZIA
is excreted in human milk.
Investigate
Benefits
Help
Navigate
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
Pre-filled syringe for self-injection
Difficult to keep up with his children
Keep his disease from getting worse
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
Jack's Living Situations
Working first job at an accounting firm
Single and living on his own
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 be more present at work and can feel more comfortable going out socially.
Lyophilized formulation for in-office administration
Pre-filled syringe for self-injection
Embarrassed to discuss his symptoms with his friends or his roommates
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
Mother often needed to remind him to take his medications
Improvements in the signs and symptoms of disease.
Improvements in quality of life.
Reductions in the likelihood of disease progression.
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
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.
Selecting a treatment that is right for her if/when she decides to start a family.
Pre-Filled Syringe

=
a helpful way to allow Sara to keep her freedoms and take her therapy on the go with her.
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
Keep his disease from getting worse.
IBDQ Response at Week 26
Disease Progression at Week 26
PRECiSE 2: Disease Progression
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.
Working first job at an accounting firm
Single and living on his own
Mother often needed to remind him to take his medications
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
Embarrassed to discuss his symptoms with his friends or his roommates
Communicate Important Safety Information and Safety Concerns
Medication Reminders
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.
29.1%
46.7%
Considered Goals
Selected Goals
Adherence
, especially in the context of a chronic disease like CD, is often a challenge.
Non-adherence to anti-TNF therapy in patients
35%
72%
Consequences of insufficiently controlled disease;
and to set
expectations
of
lifelong therapy
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
Medication reminder tools and smart phone applications
Support programs provided by pharmaceutical companies
Helps improve
physical health, life satisfaction, cognitive functioning
, and
psychological
well-being.
Anxiety
Depression
Patients with Crohn's Disease
5x more likely
to experience
Depression has a detrimental effect on a patient’s disease course, increasing the likelihood of more frequent and earlier relapses.
50%
of patients with anxiety or depression 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
range
Reminder Resources for Medicines As Prescribed
Education
Access
Emotional Well Being
Education can improve adherence to therapy for chronic diseases
Adherence
is also affected by a patient’s ability to access and pay for their medications.
Support services - Investigate benefits - Help patients navigate the process of obtaining medication


Financial assistance


In-office administration for patients who cannot self-inject
vs

Reduce the number of trips to bathroom each day so that he can be more present at work and can feel more comfortable going out socially.
Jack's Living Situations
Difficult to keep up with his children
PRECiSE 2: Quality of Life
CIMZIA should only be used during pregnancy if it is clearly needed
63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
69%
40%
Clinical Response at Week 26 for Patients with no Anti-TNF Experience
n=159
n=163
P<0.001
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Remission at Week 26 (overall)
PRECiSE 2 Results: Clinical Response and Remission
Resource Utilization
Pregnancy Exposure Registry
Patient support groups:
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
No fetal harm was observed in animal reproduction studies
It is not currently known whether
CIMZIA
is excreted in human milk.
Case Manager
Investigate
Benefits
Help
Navigate
97%
Financial Assistance
$0 COPAY
CIMZIA should only be used during pregnancy if it is clearly needed
Potential Risks of Therapy During Pregnancy
Low transfer of CIMZIA across the placenta to the infants
Pregnancy Exposure Registry
Recommend activity and exercise
Case Manager
97%
Financial Assistance
$0 COPAY
63%
36%
Clinical Response at Week 26 (overall)
n=215
n=210
P<0.001
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
69%
40%
Clinical Response at Week 26 for Patients with no Anti-TNF Experience
n=159
n=163
P<0.001
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Remission at Week 26 (overall)
n=210
n=215
P<0.001
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
IBDQ Response at Week 26
P<0.001
*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
Disease Progression at Week 26

Placebo*
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
69%
40%
Clinical Response at Week 26 for Patients with no Anti-TNF Experience
n=159
n=163
P<0.001
Placebo*
CIMZIA*

*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2: Patients with Anti-TNF–Experience
Remission at Week 26 (overall)
PRECiSE 2 Results: Clinical Response and Remission
IBDQ Response at Week 26
PRECiSE 2: Quality of Life
Clinical Response* and Remission at Week 26
PRECiSE 2: Response and Remission in Patients Diagnosed with CD 1-2 Years Before CIMZIA Use
36.4%
63%
36%
Clinical Response at Week 26 (overall)
Placebo*
50%
n=215
n=210
P<0.001
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
PRECiSE 2 Results: Clinical Response and Remission
Potential Risks of Therapy During Pregnancy
Low transfer of CIMZIA across the placenta to the infants
n=20
n=22
n=22
Lyophilized formulation for in-office administration
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
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.
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.
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.
Age
Mucosal
Healing
If symptoms persist, you should consider an agent with another MOA.
If symptoms persist, you should consider an agent with another MOA.
Switch to another anti-TNF agent.
Switching to another MOA.
To increase the dose or frequency of dosing
With
Reactive

Vs
Proactive
The CRADLE study will examine
levels of CIMZIA in breastmilk

Lyophilized formulation
for in-office administration
The CRADLE study will examine
levels of CIMZIA in breastmilk
3 of every 5 patients with 2-5 year’s disease duration responded to CIMZIA
close to
half
were in remission at
week 26.
29.1%
46.7%
vs

29%
48%
CIMZIA*
n=214
CIMZIA*
n=210
Placebo*
Placebo*
P<0.001
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
43%
60%
Placebo*
CIMZIA*
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
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
IBDQ Response: Increase of ≥16 points in IBDQ score
n=214
CIMZIA*
n=210
Placebo*
n=210
n=215
P<0.001
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
P<0.001
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
43%
60%
29%
48%
CIMZIA*
IBDQ Response: Increase of ≥16 points in IBDQ score
n=214
CIMZIA*
n=210
Placebo*
Placebo*
Response
n=20
55%
CIMZIA*
75%
Remission
CIMZIA*
Placebo*
Remission at Week 26 (overall)
PRECiSE 2 Results: Clinical Response and Remission
Clinical Response* and Remission at Week 26
*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
* Response defined as ≥100-point decrease in CDAI score from baseline at Week 26. Remission defined as CDAI score ≤150 points at Week 26.
36.4%
Placebo*
50%
n=20
n=22
n=22

n=210
n=215
P<0.001
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
29%
48%
CIMZIA*
Placebo*
Response
n=20
55%
CIMZIA*
75%
Remission
CIMZIA*
Placebo*
Lyophilized formulation for in-office administration
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
TREAT TO
TARGET

THERAPEUTIC

DRUG MONITORING

PERSONALIZED
MEDICINE

AS
PSA
CD
RA
Treatment of adult Patients with active ankylosing spondylitis (AS)

AS
PSA
Treatment of adult Patients with active psoriatic arthritis (PsA)
RA
Treatment of adults with moderately to severely active rheumatoid arthritis (RA)

RA
CD
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.
AS
PSA
CD
RA
Treatment of adult Patients with active ankylosing spondylitis (AS)

AS
PSA
Treatment of adult Patients with active psoriatic arthritis (PsA)
RA
Treatment of adults with moderately to severely active rheumatoid arthritis (RA)

RA
CD
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.
AS
PSA
CD
RA
Treatment of adult Patients with active ankylosing spondylitis (AS)

AS
PSA
Treatment of adult Patients with active psoriatic arthritis (PsA)
RA
Treatment of adults with moderately to severely active rheumatoid arthritis (RA)

RA
CD
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*400 mg at weeks 0, 2, and 4, then 400 mg every 4 weeks.
* Response defined as ≥100-point decrease in CDAI score from baseline at Week 26. Remission defined as CDAI score ≤150 points at Week 26.
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
*3 doses CIMZIA 400 mg at Weeks 0, 2, & 4, then placebo q4w
BRIEF
BRIEF
BRIEF
Full transcript