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© 2019 PRIME® Education, LLC. All Rights Reserved..

There is no fee for this activity as it is provided by PRIME® though an education grant from Genentech.


AccreditationIn support of improving patient care, PRIME® is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 2.25 Interprofessional Continuing Education (IPCE) credits for learning and change.

Physician Credit Designation StatementPRIME® designates this Enduring material for a maximum of 2.25 AMA PRA Category 1 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.Physician Assistant Credit Designation StatementThis program has been reviewed and is approved for a maximum of 2.25 hours of AAPA Category I CME credit by the Physician Assistant Review Panel. Physician assistants should claim only those hours actually spent participating in the CME activity. This program was planned in accordance with AAPA's CME Standards for Live Programs and for Commercial Support of Live Programs.Nurse Practitioner Credit Designation StatementPRIME® is approved as a provider of Nurse Practitioner Continuing Education by the American Association of Nurse Practitioners. Provider number: 060815.This activity is approved for 2.25 contact hours of continuing education (which includes 1.4 hour of pharmacology) by the American Association of Nurse Practitioners. This activity was planned in accordance with AANP Accreditation Standards and Policies.Pharmacist Credit Designation StatementThis curriculum has been approved for 2.25 contact hours (0.225 CEUs) by PRIME®. PRIME® is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Universal Activity Number for this program is JA0007144‐0000‐19‐050‐H01‐P. This learning activity is Application‐based. Your CE credits will be electronically submitted to the NABP upon successful completion of the activity. Pharmacists with questions can contact NABP customer service ([email protected]).Nurse Credit Designation StatementPRIME® designates this activity for 2.25 contact hours.

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Disclosure Policy

PRIME Education, LLC (PRIME®) endorses the standards of the ACCME, as well as those of the AANP, ANCC, and ACPE, which require everyone in a position of controlling the content of a CME/CE activity to disclose all financial relationships with commercial interests related to the activity content. CME/CE activities must be balanced, independent of commercial bias, anddesigned to improve quality in health care. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession. A conflict of interest is created when individuals in a position of controlling the content of CME/CE activities have a relevantfinancial relationship with a commercial interest which therefore may bias his/her opinion and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks, or other financial benefits. PRIME® will identify, review, and resolve all conflicts of interest that speakers, authors, course directors, planners, peer reviewers, or relevant staff disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation. Disclosure information for speakers, authors, course directors, planners, peer reviewers, and/or relevant staff is provided with this activity.Presentations that provide information in whole or in part related to non‐FDA‐approved uses of drugs and/or devices will disclose the unlabeled indications or the investigational nature of their proposed uses to the audience. Participants should refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. The opinions expressed in the educational activity are those of the presenting faculty and do not necessarily represent the views of PRIME®, ACCME, AANP, ACPE, ANCC, or other relevant accreditation bodies.


Faculty Disclosures

The following individuals have identified relevant financial relationships with commercial interests to disclose:

• Nicola A Hanania, MD, MS, FCCP (Lead Faculty, Speaker)Advisory Board/Panel – AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, GossamerBio,Mylan, Novartis, Regenron, Roche‐Genentech, Sanofi, SunovionPrincipal Investigator of Research Grant – AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Sanofi

• Bradley E Chipps, MD, FAAP, FAAA, FCCP (Speaker)Advisory Board/Panel – AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, Sanofi, TevaConsultant – AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, Sanofi, TevaSpeaker's Bureau Promotional Education – AstraZeneca, Boehringer Ingelheim, Circassia, Genentech, Novartis, Regeneron, Sanofi, Teva

• Dennis Williams, PharmD, BCPS, AE‐C (Speaker)Employed or Salary Relationship – GSK (Spouse)Stock/Shareholder (Self‐Managed) – GSK (Spouse)

The following individuals have no relevant financial relationships with commercial interests to disclose:• Heidi Wynn Maloni, PhD, ANP‐BC, CNRN, MSCN (Planner)• Joyce M Knestrick, PhD, CRNP, FAANP (Reviewer)• Mark A Rubin, MD (Planner)• Michele B Kaufman, PharmD, BCGP (Planner)

All PRIME staff participating in planning and content development have no relevant financial relationships with commercial interests to disclose.

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Learning Objectives

• Describe key research advances on the heterogeneity of asthma phenotypes and endotypes

• Differentiate established, new, and emerging targeted therapies for severe asthma by mechanisms of action, efficacy, and safety

• Assess potential applications of research on asthma heterogeneity to making personalized treatment decisions in adults with severe asthma

• Incorporate patient‐centered perspectives to guide effective decisions about the treatment and management of severe asthma

© 2019 PRIME® Education, LLC. All Rights Reserved.. 6

GINA 2019 Treatment Strategy

*Off‐label, data only with budesonide‐formoterol; †Off‐label, separate or combination ICS and SABA inhalers; $Low‐dose ICS‐formoterol is for patients prescribed budesonide‐formoterol maintenance and reliever; #Consider adding HDM SLIT for sensitized patients with allergic rhinitis and FEV >70% predicted

LTRA = Leukotriene Receptor Agonist; SABA = Short‐Acting Beta2 Agonist; LABA = Long‐Acting Beta2 Agonist; ICS = Inhaled Corticosteroid; OCS = Oral Corticosteroid.GINA. Global Strategy for Asthma Management and Prevention: 2019 Update. www.ginasthma.org. Accessed 4/11/19.

As needed low dose ICS‐formoterol*

Daily low‐dose inhaled ICS or as needed low‐dose

ICS‐formoterol*

Low‐dose ICS/LABAMedium‐dose ICS/LABA

High‐dose ICS/LABA

Refer for phenotypic assessment ± add‐on

therapy,e.g., tiotropium,

anti‐IgE, anti‐IL5/5R, anti‐IL4R

STEP 1

STEP 2STEP 3

STEP 4

STEP 5

Low‐dose ICS whenever SABA is

taken†

LTRA, or low‐dose ICS whenever SABA taken†

Medium‐dose ICS, orlow‐dose ICS + LTRA#

High‐dose ICS, add‐on tiotropium,or add‐on LTRA#

Add low‐dose OCS, but consider side effects

PREFERRED CONTROLLER

PREFERRED RELIEVER

Other controller options

As needed low‐dose ICS‐formoterol* As needed low‐dose ICS‐formoterol$

As needed SABAOther reliever option

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Real‐World Use of SABA by Patients (≥12 Years) with Asthma

Lugogo N, et al. American Thoracic Society (ATS) 2019; Dallas, TX. Abstract A5924.

Exacerbations (all patients) Low SABA Filln = 46,843Med. SABA Filln = 79,575

High SABA Filln = 46,155

Total SABA fills, mean (SD) 1.00 (0.00) 2.35 (0.48) 6.52 (3.43)Exacerbations/person/year, mean (SD) 0.55 (1.00) 0.74 (1.20) 1.05 (1.62)

Inpatient hospitalization with primary diagnosis of asthma, n (%) 247 (0.5) 743 (0.9) 906 (2.0)

Specific Service Utilization Among Non‐Chronic Systemic Steroid PatientsShort burst of corticosteroid, n (%) 15,726 (33.6) 32,209 (40.5) 21,414 (46.4)Emergency room visits, n (%) 1,070 (2.3) 3,323 (4.2) 3,092 (6.7)Other ambulatory visits, n (%) 9,568 (20.4) 20,427 (25.7) 14,217 (30.8)Inpatient hospitalization, n (%) 103 (0.2) 272 (0.3) 312 (0.7)

Presence of Specific Exacerbations by SABA Fill27.1

28.9

43.2

0.8Low SABA Fill

27.9

15.420.3

35.3

1Medium SABA Fill

20.6

12.8

19.2

45.4

2High SABA Fill

33.940.9

47.5

Percentage of Patients with ≥1 Exacerbation During the Post‐Index Period

Low SABA Fill Medium SABA Fill High SABA Fill

50

40

30

20

10

0

Well Controlledn = 46,843

(27%)

Not Well Controlledn = 79,575

(46%)

Very Poorly Controlledn = 46,155(47.5%)

SABA Usage Across GINA Treatment StepsAnalysis of 172,153 patients (≥12 y.o.) in the

MarketScan Database


Real‐World Patterns of Add On‐Therapy (LAMA vs. Biologic)in Adult Patients with Moderate‐to‐Severe Asthma

Analysis of 223,704 adult patients in the MarketScan Database (2012–2017)

– Average observation period before treatment escalation: 3.1 years

– LABA pharmacy fills ≥1 increased from 1% in 2012 to 7% in 2017

– Patients filling ≤90‐days’ cumulative supply of LABA: 35.2%

Treatment Patterns– Added LAMA without adding a biologic or prior to adding a biologic: 9.4%• Primary trend across pulmonologists

– Added a biologic without adding a LAMA or prior to adding a LAMA: 0.9%• Primary trend across allergists

– Added a biologic after adding LAMA: 3.6%– Patients initiating biologic treatment with no prior LAMA prescription: 72.7%

LAMA = Long‐Acting Muscarinic AntagonistsChen H, et al. ATS 2019; Dallas, TX. Abstract A5925.

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PROSPERO Study: Real‐World Effectiveness of Omalizumab

PROSPERO = Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to OmalizumabCasale TB, et al. American Academy of Allergy Asthma & Immunology (AAAAI) 2019; San Francisco, CA. Abstract 300.

48‐week observational study in patients ≥12 years with allergic asthma taking omalizumab

Asthma Exacerbations Asthma‐Related ER Visits

Mean number of unscheduled physician office visits was also reduced after 1 year of treatment with omalizumab

↓74%Reduction in Mean # ↓82%

Relative Reduction

Asthma‐Related Hospitalizations

↓54%Relative Reduction

4.00

3.00

2.00

1.00

0.00Mea

n (SD) Num

ber o

f As

thma Exacerations

Mea

n (SD) Num

ber o

f As

thma‐Re

lated Em

ergency

Depa

rtmen

t Visits

30

20

10

0

Percen

t of P

atients W

ith

≥1 Asthm

a‐Re

lated

Hospita

lization

0.50

0.40

0.30

0.20

0.10

0.0012 Months Before Study Entry(n = 804)

12 Months on Study Entry(n = 796)

≤90 Days Before Study Entry(n = 804)


≤90 Days Before Study Entry(n = 804)



45

27

16

18

18

19

9

11

4

9

3

3

5

13

0% 20% 40% 60% 80% 100%

A/I

Pulmonologist

Patients

Exacerbations in the Prior 12 MonthsNone 1 2 3 4 5 ≥6

CHRONICLE Study: Real‐World Treatment Patterns and Outcomes Among Adults with Severe Asthma

mSCS = Maintenance Systemic Corticosteroids; SA = Severe Asthma; PRB = Patients Receiving Biologic; PNRB = Patients NOT Receiving BiologicPanettieri RA, et al. ATS 2019; Dallas, TX. Abstract A2681; Ambrose C, et al. ATS 2019; Dallas, TX. Abstract A2678.

Overall: 65% patients had ≥1 exacerbations

Asthma Treatment Category for Eligible and Enrolled PatientsAmong Enrolled Patients, Subspecialist Providing

Care

Asthma Treatment Category

All eligible(N = 1,428)

All enrolled(n = 798)

A/I(n = 360)

Pulmonologist(n = 346)

HD ICS+, no biologics or mSCS 37% 19% 21% 21%

Biologics, no mSCS 51% 67% 73% 59%Biologics and mSCS 7% 9% 6% 13%mSCS, no biologics 5% 4% 0.6% 8%

37

12

4459

4358 6154

18

6177

6076 71

0102030405060708090

100

Receiving>500 µg FPIequivalent

daily

ReceivingmSCS

≥2 exacerbations

in prior months

Daytimesymptoms

>2x per week

Nocturnalawakening

Reliever use

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CHRONICLE Study (cont’d): Real‐World Incidence of Respiratory and Non‐Respiratory Comorbidities

Panettieri RA, et al. ATS 2019; Dallas, TX. Abstract A2681.

11

10

5

11

34

12

31

71

1

3

8

5

4

27

7

41

0 10 20 30 40 50 60 70 80 90 100

Allergic Conjunctivitis

Nasal/Sinus Polyps

Chronic Obstructive Pulmonary Disease(COPD)

Chronic Rhinosinusitis

Confirmed Allergy to Perennial Aeroallergen

Obstructive Sleep Apnea

Confirmed Allergy to Seasonal Aeroallergen

Allergic Rhinitis

Patients (%)

Respiratory Comorbidities Among Patients

Pulmonologist A/I 4

4

4

9

6

10

10

14

14

29

41

6

6

9

9

17

12

21

16

20

31

40

0 10 20 30 40 50 60 70 80 90 100

Atopic Dermatitis/Eczema

Osteopenia/Osteoporosis

Insomnia or Sleep Disturbance

Thyroid Disease

Osoteoarthritis or Unspecified Arthritis

Type 3 Diabetes

Anxiety

Hypercholesterolemia

Depression

Hypertension

Grastroesophageal Reflux Disease

Patients (%)

Nonrespiratory Comorbidities Among Patients

Pulmonologist A/I


Mepolizumab in Patients with Upper Airway Disease (UAD):Meta‐Analysis of Phase 2b/3 Trials

ACQ = Asthma Control Questionnaire; SGRQ = St. George’s Respiratory Questionnaire.Prazma MP, et al. AAAAI 2019; San Francisco, CA. Abstract 283.

Meta‐Analysis of SA Patients from the DREAM, MENSA, SIRIUS, and MUSCA Trials with Comorbid UAD (allergic rhinitis, sinusitis, or nasal polyposis)

• 59% of patients with SA reported ≥1 UAD comorbidity – Allergic rhinitis most frequent

• Reduction of exacerbations vs. placebo– Relative risk with UAD 0.49 (95% CI 0.41, 0.58), without UAD 0.55 (95% CI 0.44, 0.69)

• ACQ score improvement vs. placebo–With UAD 0.35 (95% CI 0.23, 0.48), without UAD 0.29 (95% CI 0.14, 0.44)

• SGRQ score improvement vs. placebo–With UAD 7.5 point (95% CI 5.2, 9.8), without UAD 6.1 point (95% CI 3.2, 9.1)

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Dupilumab* for Asthma with Allergic Rhinitis (AR): Post Hoc Analysis of LIBERTY ASTHMA QUEST Trial

• 63% of patients self‐reported comorbid AR • Reduction of exacerbations vs. placebo

– Relative risk with AR 0.606 (P = 0.0009), without AR 0.406 (P

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Perinatal Outcomes in Women with AsthmaTreated with Omalizumab

Namazy AN, et al. AAAAI 2019; San Francisco, CA. Abstract 3029.

EXPECT: Prospective observational study in 250 women taking omalizumab whose pregnancy outcomes were collected up to 18 months after delivery

Comparator cohort: 1,153 pregnant women not exposed to omalizumab (QECC)

8.1

0.9

15

9.78.9

0.9

11.3

15.8

Major CongenitalAbnormalities

Fetal Death orStillbirth

Premature Birth Small for GestationalAge

Preg

nancy O

utcomes (%

)

EXPECT QECC


This module is part of a video library featuring 3 additional segments.

Please note that to claim credit, participants must complete all four modules.

accreditation - prime educationmedia.primeinc.org › programs › hd › 22wb191...prior to adding...

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