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JAK-STAT-GO: Personalized, Targeted Therapy Options for Your IBD Patients in Seven Minutes or Less Enduring Final Outcomes Report Gilead Sciences Grant ID: 06050

JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

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Page 1: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

JAK-STAT-GO: Personalized, Targeted Therapy Options for Your IBD Patients in Seven Minutes or LessEnduring Final Outcomes Report Gilead Sciences Grant ID: 06050

Page 2: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Activity Description: Expert faculty from the Icahn School of Medicine at Mount Sinai, University of Chicago Medicine and Biological Sciences, and Montefiore Medical Center/Albert Einstein College of Medicine led a symposium at Digestive Disease Week™(DDW) 2019 exploring the latest in treat-to-target paradigms, the role of the JAK-STAT pathway, and related research on investigational JAK inhibitors in IBD treatment. Video excerpts from the symposium were made available as online enduring modules making it easier for the learner to move easily between topics.

Launch/Expiration: June 27, 2019 – June 27, 2020

Credit: 1.0 AMA PRA Category 1 CreditsTM

Sponsored by The Academy for Continued Healthcare Learning (ACHL).

Supported by An educational grant from Gilead Sciences, Inc.

Intended Audience: Gastroenterologists and gastroenterology allied health care professionals interested in the JAK/STAT signaling pathway and applications to treatment of IBD.

Activity Availability:• Direct Activity Link: https://www.achlcme.org/digital/DDW190/index.html• Peer Audience: https://pro-c.me/courses/index.html?collection=180200423&presentation=180200423-p1• ACHLcme.org: http://www.achlcme.org/JAK-STATProspectives

Overview

Page 3: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

FacultyBruce Sands, MD, MSChief of the Dr. Henry D. Janowitz Division of GastroenterologyDr. Burrill B. Crohn Professor of MedicineIcahn School of Medicine at Mount SinaiMount Sinai Health SystemNew York, NY

Thomas Ullman, MDChief, Division of Gastroenterology Montefiore Medical Center/Albert Einstein College of MedicineBronx, NY

Joel Pekow, MDAssistant Professor of Medicine, Section of Gastroenterology, Hepatology, and NutritionUniversity of Chicago Medicine and Biological SciencesChicago, IL

Page 4: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Final Participation2,102 Participants (1500 guaranteed); 318 Certificates Issued

Practicing Type53% Gastroenterology Physicians, 24% NPs/PAs, 23% Other HCPs

Objectivity and BalanceObjectivity and balance were rated as good/excellent by 98% of learners

Learning Objectives

99% of learners strongly agree or agree that all learning objectives were met, with an average rating of 3.44/4.0

Faculty

Bruce Sands, MD, MS, Thomas Ullman, MD, and Joel Pekow, MD were highly rated 3.62/4.0

Executive Summary

Page 5: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Executive Summary78% of learners will change their practice as a result of participating in this educational activity! 45% will select a different therapy for their patients who fail to demonstrate IBD disease remission/mucosal healing as part of a treat-to-treat strategy.

64% of learners will now consider prescribing JAK inhibitors for clinical use in IBD for specific at-risk patients as part of a treat-to-target clinical strategy.

An effect size of 0.26 indicates that learners are now ~18.66% more knowledgeable of the content assessed than prior to participating in this education.

Participants demonstrated improved knowledge and competence on six of six pre/posttest questions.

Safety of JAK Inhibitors was rated with highest interest for future education.

Changes will impact 1,200 to more than 2,847 IBD patients each month.

Page 6: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Safety of JAK inhibitors from emerging IBD clinical trials

and rheumatology perspectives

Differentiating between available and emerging JAK inhibitors, including

MOA, efficacy, and safety

Icon made by FreePik from www.flaticon.com

Incorporating JAK therapy into current treat-to-target

paradigms

Future Education Opportunities

Clinical trial updates in JAK therapies, including study

populations, efficacy endpoints, and onset of

action

Page 7: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Activity Screenshots

Page 8: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Participation

53%

24%

23%

Participation by Target Audience

US Gastroenterology Physicians

NPs/PAs

Others (Ex-US Physicians,General Practice, Cardiology)

Participants Certificates Issued2,102 318 6%

7%

16%

66%

5%Years in Practice

1-3

4-8

9-15

>16

N/A (not practicing)

N=653

18%

52%

28%4%

Practice Setting

Teaching Hospital

Community Hospital

Private Practice

N/A (not practicing)

Page 9: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Participation Geographic Makeup

36%

7%

57%

Device usage

Smartphone Tablet MAC/PC

Page 10: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Learning ObjectivesPlease rate the following objectives to indicate if you are better able to: Analysis of Respondents

Rating scale: 4=Strongly Agree;

1=Strongly Disagree

Discuss the role of the JAK/STAT signaling pathway in the pathogenesis of IBD and the rationale for inhibition 3.5

Compare and contrast the cytokine pathways targeted by available and emerging JAK inhibitors in IBD 3.4

Interpret the clinical trial efficacy and safety data of JAK inhibitors investigated for Crohn’s disease and ulcerative colitis 3.4

Identify IBD patients who require a change in therapy 3.5

N=318

99% of learners would recommend this activity to a colleague

According to 98% of the learners, the content contributed valuable information that will assist in improving the quality of IBD care for their patients.

Page 11: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Objectivity & Balance

Activity was perceived as objective, balanced and non-biased.

62%

36%

2%0%

10%

20%

30%

40%

50%

60%

70%

Excellent Good Fair Poor

Rating of objectivity & balance

N=318

99%

1%

Did you perceive any bias?

No Yes

Page 12: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Cohen’s d Effect Size: All Learners

Pre-Test Post-Test

49%Mean

0.26Standard Deviation

256Sample Size

56%Mean

0.28Standard Deviation

256Sample Size

Cohen’s d Effect Size = .26

This Effect Size calculation uses first-attempt posttest data, includes all completers (paired data only) and encompasses all six pretest and posttest questions.

An effect size of 0.26 indicates that learners are now ~18.66% more knowledgeable of the content assessed than prior to participating in this education.

Cohen (1988): .2 = small, .5 = medium, .8 = largeWolf (1986): .25 = educationally significant, .50 = clinically significant

Page 13: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Effect Size to Non-Overlap Conversion TableEffect Size Percent of

Non-Overlap Effect Size Percent of Non-Overlap Effect Size Percent of

Non-Overlap0.10 7.7 0.75 45.2 1.40 68.1

0.15 11.2 0.80 47.4 1.45 69.4

0.20 14.7 0.85 49.5 1.50 70.7

0.25 18.0 0.90 51.6 1.55 71.9

0.30 21.3 0.95 53.5 1.60 73.1

0.35 24.4 1.00 55.4 1.65 74.3

0.40 27.4 1.05 57.2 1.70 75.4

0.45 30.2 1.10 58.9 1.75 76.4

0.50 33.0 1.15 60.6 1.80 77.4

0.55 35.6 1.20 62.2 1.85 78.4

0.60 38.2 1.25 63.8 1.90 79.4

0.65 40.6 1.30 65.3 1.95 80.2

0.70 43.0 1.35 66.7 2.00 81.1

Gilead ME&P_Presentation_Outcomes Needs dated 11/6/18

Page 14: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Outcomes Reporting Methodology• First-attempt posttest scores are reported throughout:

• Initial answer choices for the posttest provide insight into the learners’ ability to immediately recall and apply the education.

• For post-activity questions administered as part of the evaluation (versus the posttest), only first-attempt was collected.

• Pre- and posttest responses have been paired/matched. Non-completer data has been omitted from the analysis to ensure comparison groups are equivalent.

Page 15: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Pretest vs. Posttest SummaryAggregate Learners

Participants demonstrated improved knowledge and competence on six of six pre/posttest questions.

85%

22%29%

15%

25%

62%

87%

27% 30% 29% 32%

71%

93%

72%

59%55%

61%

84%

0%

20%

40%

60%

80%

100%

1 2 3 4 5 6

Pre First Post Final Post

Topic % Change(pre to first post)

% Change (pre to final post)

1 Treat-to-Target Approaches 2% 9%

2 JAK Inhibitor MOA 23% 227%

3 Clinical Trial Data 3% 103%

4 Therapeutic Targets 93% 267%

5 Investigational JAK Inhibitors 28% 144%

6 Safety of JAK Inhibitors 15% 35%

Overview of Correct Responses

Page 16: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Clinical Competence: Treat-to-Target

3%

7%

85%

5%

4%

4%

87%

5%

2%

3%

93%

2%

Continue vedolizumab for another 3 months; monitor patientfor improved clinical response

Switch to sulfasalazine; monitor patient for clinical responseover next 3 months

Switch to tofacitinib; monitor patient for clinical response overnext 3 months

Refer patient for colectomy

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)

1. 36-year old woman with UC with bloody stools 6 times a day and colonoscopy has Mayo endoscopic subscore of 2. Treated first with infliximab; there was no clinical response. 6 months later, still no clinical response/active inflammation showed on colonoscopy/negative C. diff and CMV, and trough infliximab is 12. Switched to vedolizumab; 6 months later, no clinical response/continued active inflammation on scope/negative infectious workup.

Under the treat-to-target (T2T) clinical management paradigm for UC, which of the following is the BEST next course of action for this patient?

Aggregate Data: Treat-to-Target Approaches

Page 17: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

11%

22%

55%

12%

13%

8%

64%

15%

6%

5%

85%

4%Pre-test (n = 43)

First Post (n = 43)

Final Post (n = 43)

Clinical Competence: Treat-to-Target

1. 36-year old woman with UC with bloody stools 6 times a day and colonoscopy has Mayo endoscopic subscore of 2. Treated first with infliximab; there was no clinical response. 6 months later, still no clinical response/active inflammation showed on colonoscopy/negative C. diff and CMV, and trough infliximab is 12. Switched to vedolizumab; 6 months later, no clinical response/continued active inflammation on scope/negative infectious workup.

Under the treat-to-target (T2T) clinical management paradigm for UC, which of the following is the BEST next course of action for this patient?

Specialty Breakdown: Treat-to-Target Approaches

Continue vedolizumab for another 3 months; monitor

patient for improved clinical response

Switch to sulfasalazine; monitor patient for clinical

response over next 3 months

Switch to tofacitinib; monitor patient for clinical response

over next 3 months

Refer patient for colectomy

Gastroenterologists NPs and PAs Others

1%

3%

93%

3%

2%

2%

94%

2%

1%

1%

97%

1%Pre-test (n = 163)First Post (n = 163)Final Post (n = 163)

4%

10%

80%

6%

6%

8%

77%

9%

3%

7%

87%

3%Pre-test (n = 50)

First Post (n = 50)

Final Post (n = 50)

Across the specialties, learners demonstrated high baseline

knowledge regarding the best course of action under the treat-to-target clinical management

paradigm for UC, with a modest increase after participation.

These results indicate learner competency in the selection of

therapy for patients with an inadequate response to therapy, with gastroenterology learners

demonstrating highest competency post activity.

Page 18: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Knowledge Acquisition: JAK1 MOA

22%

18%

23%

37%

27%

13%

23%

37%

42%

12%

22%

24%

50%

20%

14%

16%

JAK1

JAK1/2

JAK1/3

JAK1/2/3 and Tyk2

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)Follow-up (n = 50)

2. The available and emerging JAK inhibitors inhibit different members of the JAK family in their approach to IBD management. The investigational agent filgotinib works by inhibiting which of the following?

Aggregate Data: JAK Inhibitor MOA

Page 19: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

13%

18%

23%

46%

25%

20%

15%

40%

47%

8%

19%

26%

47%

24%

5%

24%

Pre-test (n = 50) First Post (n = 50)Final Post (n = 50) Follow-up (n = 21)

26%

16%

23%

35%

31%

9%

26%

34%

41%

12%

25%

22%

59%

23%

18%

Pre-test (n = 163) First Post (n = 163)Final Post (n = 163) Follow-up (n = 22)

16%

25%

25%

34%

18%

18%

19%

45%

41%

17%

13%

29%

29%

29%

43%

Pre-test (n = 43) First Post (n = 43)Final Post (n = 43) Follow-up (n = 7)

Knowledge Acquisition: JAK1 MOA

2. The available and emerging JAK inhibitors inhibit different members of the JAK family in their approach to IBD management. The investigational agent filgotinib works by inhibiting which of the following?

Specialty Breakdown: JAK Inhibitor MOA

JAK1

JAK1/2

JAK1/3

JAK1/2/3 and Tyk2

Gastroenterologists NPs and PAs Others Learners demonstrated low baseline knowledge of the MOA of filgotinib.

Following the activity there were modest increases in knowledge

among learners; however, more than one-half of all learners were still

unable to identify the MOA of filgotinib. These results likely reflect that JAK inhibition is a relatively new target in IBD. The follow-up survey results indicate some knowledge

retention and further gains in gastroenterologists, which may be attributed to increased education to

this important target audience. However, these data indicate a need for continued education differentiating the MOAs of available and emerging

JAK inhibitors for IBD.

Page 20: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Knowledge Acquisition: Trial Data

17%

29%

43%

11%

23%

30%

37%

10%

17%

59%

20%

4%

47% in filgotinib group, vs. 25% in placebo group

54% in filgotinib group, vs. 39% in placebo group

60% in filgotinib group, vs. 13% in placebo group

There was no statistically significant difference in CDAIreduction between the two patient subsets.

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)

3. According to the FITZROY trial which evaluated efficacy of filgotinib versus placebo in the treatment of Crohn’s disease, which of the following is an accurate representation of the achievement of clinical response (defined as 100-point reduction in CDAI) in the anti-TNF-experienced patient subset?

Aggregate Data: Clinical Trial Data

Page 21: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

18%

37%

31%

14%

21%

41%

14%

24%

13%

75%

7%

5%

Pre-test (n = 43)First Post (n = 43)Final Post (n = 43)

Knowledge Acquisition: Trial Data

3. According to the FITZROY trial which evaluated efficacy of filgotinib versus placebo in the treatment of Crohn’s disease, which of the following is an accurate representation of the achievement of clinical response (defined as 100-point reduction in CDAI) in the anti-TNF-experienced patient subset?

Specialty Breakdown: Clinical Trial data

47% in filgotinib group, vs. 25% in placebo group

.

54% in filgotinib group, vs. 39% in placebo group

60% in filgotinib group, vs. 13% in placebo group

There was no statistically significant difference in CDAI

reduction between the two patient subsets

Gastroenterologists NPs and PAs Others

19%

26%

43%

12%

24%

28%

43%

5%

20%

53%

23%

4%Pre-test (n = 163)First Post (n = 163)Final Post (n = 163)

13%

30%

53%

4%

20%

26%

42%

12%

11%

67%

22%

Pre-test (n = 50)First Post (n = 50)Final Post (n = 50)

Learner knowledge of these clinical trial results was suboptimal with minimal improvement despite

faculty discussion of the FITZROY clinical trial and its endpoints.

Future education should address the study populations,

interventions, and primary efficacy endpoints of clinical trials with the

JAK inhibitors across all audiences. This will be increasingly important as more clinical trial data

become available, and interpretation of these data will

guide clinical decisions.

Page 22: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Knowledge Acquisition: Therapeutic Targets

15%

11%

50%

24%

29%

10%

39%

22%

55%

9%

25%

11%

Normalization of fecal calprotectin

Resolution of rectal bleeding

Normalization of bowel habit

Normalization of endoscopic appearance

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)

4. Which of the following is NOT currently considered an evidence-based target in the treat-to-target clinical management strategy for ulcerative colitis?

Aggregate Data: Therapeutic Targets

Page 23: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

13%

19%

52%

16%

15%

19%

37%

29%

41%

14%

17%

28%

Pre-test (n = 43)First Post (n = 43)Final Post (n = 43)

Knowledge Acquisition: Therapeutic Targets

4. Which of the following is NOT currently considered an evidence-based target in the treat-to-target clinical management strategy for ulcerative colitis?

Specialty Breakdown: Therapeutic Targets

Normalization of fecal calprotectin

Resolution of rectal bleeding

Normalization of bowel habit

Normalization of endoscopic appearance

Gastroenterologists NPs and PAs Others

16%

9%

51%

24%

34%

8%

39%

19%

55%

9%

29%

7%Pre-test (n = 163)First Post (n = 163)Final Post (n = 163)

16%

14%

42%

28%

25%

12%

39%

24%

69%

6%

19%

6%

Pre-test (n = 50)First Post (n = 50)Final Post (n = 50)

First attempt post shifts were moderate; however, once learners had an opportunity to reevaluate

their answer choice, they demonstrated a shift in their ability

to correctly identify fecal calprotectin as the factor that is not

currently recommended or supported by evidence. As first

attempt post was low, future education should include up-to-date

information on the use of clinical, symptoms and laboratory markers

in treat-to-target paradigms to guide selection of therapy and improve

patient outcomes.

Page 24: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Knowledge Acquisition: Investigational Agents

25%

11%

21%

43%

32%

12%

17%

39%

61%

10%

11%

18%

Filgotinib and upadacitinib

Peficitinib an dbaricitinib

Baricitinib and abatecept

Tofacitinib and filgotinib

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)

5. Which of the following JAK inhibitors are currently in late-stage (Phase 2b, Phase 3) clinical trials for use in IBD (CD, UC, or both)?

Aggregate Data: Investigational JAK Inhibitors

Page 25: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

21%

8%

29%

42%

17%

8%

17%

58%

56%

6%

25%

13%

Pre-test (n = 43)First Post (n = 43)Final Post (n = 43)

Knowledge Acquisition: Investigational Agents

5. Which of the following JAK inhibitors are currently in late-stage (Phase 2b, Phase 3) clinical trials for use in IBD (CD, UC, or both)?

Specialty Breakdown: Investigational JAK Inhibitors

Filgotinib and upadacitinib

Peficitinib and baricitinib

Baricitinib and abatacept

Tofacitinib and filgotinib

Gastroenterologists NPs and PAs Others

30%

12%

16%

42%

40%

16%

12%

32%

66%

13%

6%

15%Pre-test (n = 163)First Post (n = 163)Final Post (n = 163)

16%

12%

28%

44%

26%

6%

29%

39%

49%

5%

15%

31%

Pre-test (n = 50)First Post (n = 50)Final Post (n = 50)

Gastroenterologists demonstrated a minimal shift in knowledge of the

JAK inhibitors under investigation for IBD upon first attempt post. While

final post shows an increase in knowledge, future

education should include differentiation of the MOAs

and efficacy of these investigational agents

specifically.

Page 26: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Clinical Competence: Safety

6%

20%

62%

12%

6%

14%

71%

9%

3%

7%

84%

6%

8%

34%

52%

6%

Malignancies, other than non-melanoma skincancers

Serious infections

Herpes zoster infection

GI perforations

Pre-test (n = 256)First Post (n = 256)Final Post (n = 256)Follow-up (n = 50)

6. AM, a 45-year old woman who is considering initiation of a JAK inhibitor asks about the potential risk of developing cancer given her knowledge of the biologic therapies. Based on a long-term analysis of the safety of tofacitinib for the treatment of RA, which of the following would you highlight as having the highest incidence rate during your discussion with AM?

Aggregate Data: Safety of JAK Inhibitors

Page 27: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

10%

30%

29%

31%

13%

18%

49%

20%

3%

10%

70%

17%

14%

57%

15%

14%

Pre-test (n = 43)First Post (n = 43)Final Post (n = 43)

Clinical Competence: Safety

6. AM, a 45-year old woman who is considering initiation of a JAK inhibitor asks about the potential risk of developing cancer given her knowledge of the biologic therapies. Based on a long-term analysis of the safety of tofacitinib for the treatment of RA, which of the following would you highlight as having the highest incidence rate during your discussion with AM?

Specialty Breakdown: Safety of JAK Inhibitors

Malignancies, other than non-melanoma skin cancers

Serious infections

Herpes zoster infection

GI perforations

Gastroenterologists NPs and PAs Others4%

15%

75%

6%

3%

12%

80%

5%

2%

5%

91%

2%

9%

23%

68%

Pre-test (n = 163) First Post (n = 163)

Final Post (n = 163) Follow-up (n = 22)

8%

29%

46%

17%

12%

17%

57%

14%

8%

8%

75%

9%

5%

37%

48%

10%

Pre-test (n = 50)First Post (n = 50)Final Post (n = 50)

Learners demonstrated increased awareness of the most common

adverse event observed in the RA literature, with gastroenterologists demonstrating higher knowledge than other specialties. However, the follow-up survey data are not

indicative of sustained knowledge. Safety of these agents is an

important aspect since this is a relatively new target in

gastroenterology. Future education should continue to

address safety data and include perspectives from rheumatologists who likely have more experience

with this class of agents, as confidence in the safety of these

agents may translate into increased clinical application.

Page 28: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Confidence Assessment: Therapy Selection

6%

41%

53%

20%

69%

11%

24%

70%

6%

Very confident

Somewhat confident

Not at all confident

Pre-test (n = 256) Post (n = 256)Follow-up (n = 50)

7. How confident are in you prescribing the currently FDA-approved JAK inhibitor for your patients with IBD?

Aggregate Data: Therapy Selection

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4%

33%

63%

20%

64%

16%

14%

72%

14%

Pre-test (n = 43)

Post (n = 43)

Follow-up (n = 7)

Confidence Assessment: Therapy Selection

7. How confident are in you prescribing the currently FDA-approved JAK inhibitor for your patients with IBD?

Specialty Breakdown: Therapy Selection

Very confident

Somewhat confident

Not at all confident

Gastroenterologists NPs and PAs Others

6%

50%

44%

22%

69%

23%

68%

9%

Pre-test (n = 163)

Post (n = 163)

Follow-up (n = 23)

4%

33%

63%

15%

72%

13%

19%

71%

10%

Pre-test (n = 50)

Post (n = 50)

Follow-up (n = 21)

The percentage of learners reporting being very/somewhat

confident in prescribing the available JAK inhibitor for IBD increased from approximately 47% across specialists pre-

activity to 79% after participation with evidence of

retained confidence in the follow-up survey.

Future education should continue to focus on new and emerging JAK inhibitors and

application to practice.

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Practice Change

11%

25%

64%

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

I will wait until additional safety data are available

I will wait to hear of expereinces from my colleagues

I will consider them for specific at-risk patients as part of atreat-to-target clinical strategy

64% of learners will now consider prescribing JAK inhibitors for clinical use in IBD for specific at-risk patients as part of a treat-to-target clinical strategy.

Now that you have seen a snapshot of the 2019 systematic review of JAK inhibition clinical safety data, how likely are you toconsider prescribing JAK inhibitors for clinical use in IBD, either now or in the future?

N=318; multiple responses allowed

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Practice Change

30%

8%

30%

40%

22%

5%

41%

45%

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

This activity validated my current practice; no changes willbe made

Other change

Create/revise targeted therapeutic IBD protocols, policies,and/or procedures.

Select a different therapy for my patients who fail todemonstrate IBD disease remission/mucosal healing as part

of a treat-to-target strategy.

Post (n = 318)Follow-up (n = 50)

78% of learners will change their practice as a result of participating in this educational activity! 45% will select a different therapy for their patients who fail to demonstrate IBD disease remission/mucosal healing as part of a treat-to-treat strategy.

Of those who completed the 30-day follow-up survey, 70% attest to making changes in their practice.

Please identify how you will change your practice as a result of participating in this activity:

N=318; multiple responses allowed

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Change Implementation

22%

6%

12%

14%

46%

0% 10% 20% 30% 40% 50% 60% 70%

N/A

In six months

In three months

In one month

Immediately

46% of learners plan to incorporate changes into their clinical practice immediately as a result of participating in this activity!

N=318

How soon do you intend to incorporate changes into your clinical practice as a result of this CME activity?

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8%

48%

33%

9%

2%

Post (n = 141)

9%

59%

22%

10%Post (n = 39)

Patient Care Impact

Number of patients with IBD seen per month:

Specialty Breakdown: Patient Impact

Gastroenterologists NPs and PAs Others

Changes will impact 1,200 to more than 2,847 IBD patients each month. This assumes data in the chart above is representative of all HCP respondent (211), who indicated they would change their practice as a result of their participation in this activity (78%).

9%

49%

17%

11%

14%

Post (n = 31)

8%

50%29%

10%3%

0

1-10

11-20

21-50

>50

Aggregate

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Activity ImpactSelf-reported change in practice• There are sufficient data to support the safety advantage of selective

class over jak inhibitor tofacitinib• Safety of jak inhibitors• Use jak inhibitors earlier• Administer different tx modalities; assist in dx• Adopt test to target strategy, consider jak inhibitors• Await further jak inhibitors approvals for crohn's disease.• Aware of herpes zoster and importance of t2t• Change therapy more quickly use jak 1• Changing therapy sooner if treatment targets not met at 3 months.• Considering the use of jak 1,treat to target for all my patients• Consider jak as firstline, use Shingrix• Consider jak inhibitors as first line therapy• Evaluate jak inhibitors as combination therapy or induction therapy• Consider jak treatment in my pts..zoster vaccine in all ibd pts• Consider switch of therapy earlier t2t• Consider tofa sooner, practice t2t• Consider use of new & emerging treatment modalities• offer patients more treatment options.• Consider using jaks for treatment of ibd• Consideration earlier jak2 use• Considering the efficiency and side effects of jak therapies• Earlier consideration of a jak inhibitor as a therapeutic option.• Earlier use of jak1 inhibitors. increase follow-up colonoscopies.

• Early referral of ibd patients for specific biological therapy• Early referral, aggressive management• Early trials on tofacitinib did not demonstrate efficacy in crohn's

disease, although efficacy has been shown with filgotinib in the fitzroytrial.

• jak inhibitors are small molecule drugs, not proteins, and would not be expected to be lost through the inflamed mucosa of severe ibd, unlike that seen in biological therapy such as infliximab.

• Efficacy of jak inhibitors• Efficacy and safety jak inhibitors in patients with uc• Enforced the differences among the jak inhibitors and the indications• Ensure close follow up and change therapy accordingly.• Expect early onset of response vs. biologics and consider using in

those w/ hard to achieve levels w/ biologics/tnfs w/ no abs. vaccinate w/ Shingrix if going to start on tofa.!

• Fitzroy trial references• see how inflammation can affect mental conditions• Follow guidelines. select alternative therapy that work for patient.• Follow small molecules and other emerging therapies• Helps me identify appropriate patients for jak therapy and biologics as

well as discuss safety benefit of use and options.• Hold surgery until all medical rx has failed; maintain updates on jak

research• I had never heard of jak prior to this. I intend to become more familiar

as more information becomes available.

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Activity ImpactSelf-reported change in practice• In what type of patient would benefit from change in medical tx.• Safety issues with jak inhibitor therapy- need for vaccination prior to

initiating tx• Incorporate jak therapy, read more clinical study results• Jak is a good and safe option• Jaks are not biologicals• broad spectrum of inhibition with currently approved jak• Management extremely complex, interest in approach to pediatric

patient population• May use jak inhibitors to induce remission may use as 3 rd line rx• More aggressive with treatment. change therapy after 3 to 6 month of

failure• More rigid "rx to target" approach• consider using jak-1 rx more often• Review new data on jak inhibitors in inflammatory diseases• Review pathophysiology, start tofacitinib• Rx to target and use of tofa• Safety and tolerated treatment.• Safety profile of jak is actually pretty good• Small molecules and easy to administer; pre-cancer evaluation and

pre-administration of rhzv.

• Start treating with jak inhibitors when indicated. Make sure patients are well educated re their disease and all possible treatments.

• Switch meds earlier if no response within 3 months• Think about non melanoma skin cancers and consider tofacitinib earlier

in those who have developed antibodies to biologics• To consider infliximab in treatment of rheumatoid, crohns...• Treat to target-based discussion with patient/family.• Close monitoring and reevaluation in 3 months prior to consideration of

change of therapy.• Treat to target based on guidelines presented here for uc and cd plus

consider jak inhibitor for new uc patients• Understand role of jak inhibition use jak inhibitors earlier• Use jaks earlier as an option vaccinate potential all ibd pt’s for shingles• Vaccinate with zoster, watch for thrombosis risk• Will feel more comfortable offering a jak inhibitor to my uc patients. I

will be able to better educate my patients on upcoming jak 1 inhibitor therapies.

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1

2

3

4

Coverage, prior authorization,

reimbursement, cost

Insurance Barriers

Compliance, adherence, education,

uncertainty

Patient Barriers

Access, formulary-availability

Availability Barriers

Guidelines, long-term results, lack of

experience

Hesitancy Barriers

Self-reported Barriers to Change

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Topics of Interest

3%

15%

32%

36%

37%

40%

41%

-10% 10% 30% 50% 70%

Other

Assisting patients with access to JAK inhibitor therapy

Incorporating JAK therapy into treatment

Clinical trial updates in JAK therapies

Efficacy of JAK inhibitors

Case-based education

Safety of JAK inhibitors

Safety of JAK Inhibitors was rated with highest interest for future education (41%), followed by case-based education (40%) and efficacy of JAK inhibitors (37%).

N=318; multiple responses allowed

Page 38: JAK-STAT-GO: Personalized, Targeted Therapy Options for ... · Bruce Sands, MD, MS. Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Burrill B. Crohn Professor

Contact InformationBrittany PusterVP, Education DevelopmentAcademy for Continued Healthcare Learning (ACHL)

E: [email protected]: 773-714-0705 ext. 134C: 303-829-2562