Arthritis: Incorporating

Transcription

1 From Psoriasis to Psoriatic Arthritis: Incorporating Advances to Individualize Treatment Interim Outcomes Report Celgene Grant #20502 Janssen Grant #CE15843 Novartis Grant #NGC29612 Reflective of data through April 15, 2018

2 Overview Activity Description: Credit: Sponsored by: Supported by: Intended Audience: Outcomes Methodology: This series consisted of (6) live Visiting Professorship Programs (VPPs) that took place from November 2017 to April 2018, as well as a certified online enduring webcast that launched September 1, 2017 and is valid for one year AMA PRA Category 1 Credit(s) TM 0.10 pharmacy CEUs Purdue University College of Pharmacy Academy for Continued Healthcare Learning (ACHL) Celgene, Janssen, and Novartis Dermatologists, rheumatologists, primary care providers, nurse practitioners, pharmacists, and other clinicians involved in the diagnosis and treatment of patients with psoriasis and psoriatic arthritis Changes in clinician knowledge, competence, and practice were assessed through pre/post-test questions, an evaluation survey, and 45-day follow-up survey

3 Live Visiting Professorship Programs DATE LOCATION LEARNERS FACULTY November 14, 2017 Community Hospital East Indianapolis, IN 18 Sahand Rahnama-Moghadam, MD Indiana University School of Medicine Indianapolis, IN Mrisa Sahai, MD, RhMSUS Indiana University School of Medicine Indianapolis, IN December 20, 2017 Paoli Hospital Paoli, PA 37 Alexis R. Ogdie-Beatty, MD, MSCE University of Pennsylvania School of Medicine Philadelphia, PA February 21, 2018 John D. Dingell VA Medical Center Detroit, MI 28 Sahand Rahnama-Moghadam, MD Indiana University School of Medicine Indianapolis, IN Mrisa Sahai, MD, RhMSUS Indiana University School of Medicine Indianapolis, IN

4 Live Visiting Professorship Programs DATE LOCATION LEARNERS FACULTY March 6, 2018 April 10, 2018 April 14, 2018 St. Vincent s East Birmingham, AL Houston Northwest Medical Center Houston, TX Delaware County Memorial Hospital Drexel Hill, PA Maria I. Danila, MD, MSc, MSPH UAB School of Medicine Birmingham, AL Sandeep Krishna Agarwal, MD, PhD Baylor College of Medicine Houston, TX Alexis R. Ogdie-Beatty, MD, MSCE University of Pennsylvania School of Medicine Philadelphia, PA

5 Enduring Webcast FACULTY Kenneth B. Gordon, MD Medical College of Wisconsin Milwaukee, WI Alexis R. Ogdie-Beatty, MD, MSCE University of Pennsylvania School of Medicine Philadelphia, PA achlcme.org/psoriasis

6 Executive Summary: Levels 1-2 Participation 1,125 Participants (inclusive of live and enduring); 933 Certificates Practicing Type 34% Physician, 27% Physician Assistant, 13% Nurse or NP, 3% Pharmacist Participant Satisfaction Objectivity and balance rated as good/excellent by 93% of learners Learning Objectives Learners agreed or strongly agreed that all learning objectives were met, with an average rating of 3.50/4.00 Faculty Faculty were highly rated, receiving a 3.50/4.00 or higher across all domains

7 Executive Summary: Levels % indicated the activity will improve their patient outcomes, or that their current treatment practices were validated Practice changes from this activity will impact from 2,753 to more than 8,652 patients each month Participants indicated a) lack of opportunity (patients) and b) lack of experience as the most common barriers to implementing changes in practice 45 days post-activity, 93% of learners made at least one screening-related change to their practice, while 81% made at least one treatment-related change The link between psoriasis and depression (41%) was the most highly rated educational topic of future interest, followed by cardiovascular issues in psoriasis/psa (29%)

8 Level 1: Participation Participants 1,125 Total 909 Enduring 216 Live Physician Participation by Clinician Type Physician Assistant Nurse or NP Pharmacist Other HCP 3% 13% 23% Certificates 933 Total 766 Enduring 167 Live Enduring Guarantee = 1,200 Participants; 450 Certificates (met gty!) 34% 27% Participation by Specialty Family Medicine/General Practice Emergency Medicine Internal Medicine Dermatology Surgery Pediatrics Cardiology 47% Other 3% 3% 5% 22% 7% 7% 6%

9 Level 2: Learning Objectives Please rate the following objectives to indicate if you are better able to: Outline the immunologic pathways that contribute to the skin and joint manifestations of psoriasis and psoriatic arthritis Analysis of Respondents Rating scale: 4=Strongly Agree; 1=Strongly Disagree 3.47 Compare and contrast available therapies, their targets, and clinical application 3.51 Discuss patient-specific factors that may inform selection of therapy across the disease course to ensure response Critically assess the mechanisms of action, efficacy, and safety of emerging therapies for psoriasis and psoriatic arthritis Learners agreed or strongly agreed that all learning objectives were met, with an average rating of 3.50 out of N=700

10 Level 2: Satisfaction Overall Evaluation Analysis of Respondents Rating scale: 4=Excellent; 1=Poor Quality of educational content 3.56 Quality of educational materials 3.56 Effectiveness of teaching method used 3.55 Appropriateness and effectiveness of active learning strategies 3.56 All aspects of the activity were highly rated at 3.55/4.00 or higher. 82% felt the activity content matched their current or potential scope of practice. N=700

11 Level 2: Faculty Evaluation Please rate the faculty on the criteria listed Rating scale: 4=Excellent; 1=Poor Ability to effectively convey the subject matter Ability to present scientifically rigorous information Sandeep Krishna Agarwal, MD, PhD Maria I. Danila, MD, MSc, MSPH Alexis R. Ogdie-Beatty, MD, MSCE Sahand Rahnama-Moghadam, MD Mrisa Sahai, MD, RhMSUS Enduring Faculty (Drs. Gordon and Ogdie-Beatty) N=700 Learners reported that faculty were good or excellent in all domains, with a rating of 3.50/4.00 or higher in both assessment areas.

12 Objectivity & Balance Did you perceive any bias? 7% Yes No 93% N=700 Activity was perceived as objective, balanced and non-biased.

13 Levels 3-4: Confidence Psoriasis/PsA Screening/Diagnosis How confident are you in recognizing the signs and symptoms of psoriasis and/or psoriatic arthritis? A. Very confident B. Somewhat confident C. Somewhat not confident D. Not at all confident While just 70% of participants reported feeling somewhat or very confident in recognizing psoriasis/psa signs and symptoms at pre-test, this number rose to 100% at the 45-day follow-up survey. This dramatic increase indicates high educational impact of the activity. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) Enduring 45-day Follow-up (n=18) 67% 57% 50% 51% 32% 33% 28% 20% 18% 16% 12% 9% 5% 2% A B C D

14 Levels 3-4: Pretest vs. Posttest 100% 80% 60% 40% 20% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 94% 88% 89% 77% 80% 73% 59% 56% 57% 51% 55% 44% 36% 27% 28% 22% 69% 25% 0% Topic: % Increase Enduring % Increase Live All-Cause Mortality CV Comorbidities PsA Comorbidities PSO to PsA Progression All-Cause Mortality CV Comorbidities PsA Comorbidities PSO to PsA Progression Oral Treatment Agents Oral Treatment Agents CV Event Management CV Event Management 185% 100% 81% 65% 103% 214% 119% 82% 25% 54% 147% 14% Learners showed increased knowledge/competence on all six pre/post-test questions.

15 Levels 3-4: Pretest vs. Posttest All-Cause Mortality What is the approximate likelihood that patients with more severe psoriasis (>10% BSA) will die in the next 5 years (via all-cause mortality) compared to the general population? A. At least 5 times (5X) more likely B. At least 1.5 times (1.5X) more likely C. At least 2 times (2X) more likely D. There is no statistically significant difference in mortality Learners displayed increased knowledge regarding psoriasisrelated mortality rates. 27% answered correctly at pre-test, while 77% and 59% answered correctly at the enduring and live posttests, respectively. This represents a 185% increase in knowledge for enduring participants and a 119% increase in knowledge for live participants. Given the critical nature of all-cause mortality prevention among psoriasis patients, these metrics indicate the importance of effective continuing education on these topics. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 77% 59% 35% 25% 27% 19% 19% 12% 10% 7% 6% 4% A B C D

16 Levels 3-4: Pretest vs. Posttest Cardiovascular Events Psoriasis patients with >10% BSA are at increased risk of morbidity and mortality from major adverse cardiac events (MACEs), renal disease, liver disease, and other myriad factors. Meanwhile, psoriatic arthritis (PsA) patients also have a higher risk of MACE compared to the general population. Within this clinical context, which one of the following statements is also true? A. TNF-α inhibitors are approximately six times as effective as methotrexate at preventing MACE in patients with psoriasis B. Depression and/or suicidal ideation are not statistically significant causes of morbidity and mortality in the PsO/PsA population. C. Adalimumab, etanercept, and infliximab are all therapies which are safe to use without restriction in PsA patients with cardiovascular comorbidities such as CHF. D. NSAIDs should be considered carefully in patients with preexisting heart disease and may generally be avoided if possible. Learners showed increased competence in managing cardiovascular comorbidities, with a 100% increase in the number of correct responses from enduring pre to post-test. However, with only 56% of enduring participants and 51% of live participants answering this question correctly, there is still a strong need for continuing education surrounding cardiovascular events in PSO patients. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 36% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 9% 36% 18% 18% 7% 3% 28% 10% 28% A B C D 56% 51%

17 Levels 3-4: Pretest vs. Posttest Comorbidities in PSA Patients Which of the following are signs/symptoms of PsA which may also be a sign of concurrent axial disease (termed psoriatic spondylitis or ankylosing spondylitis)? A. Dactylitis (aka sausage digit ) of the fingers and/or toes B. Low back or gluteal stiffness when getting out of a car, or morning stiffness in the lower back/lower body area lasting 45 min C. Psoriatic nail dystrophy. D. Radiographic evidence of juxta-articular new bone formation of the peripheral joints Regarding PsA comorbidities, the number of correct responses increased by 36 percentage points from enduring pre to post-test, with just 44% answering correctly at pre-test and 80% answering correctly at post-test, indicating highly effective education on this clinical topic. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 80% 55% 44% 27% 29% 15% 14% 12% 5% 7% 8% 4% A B C D

18 Levels 3-4: Pretest vs. Posttest Patient Case PSO to PsA Disease Management Patient NCD received a PsO diagnosis 5 years ago; with BSA coverage >50%. She received a standard dose of adalimumab 4.5 years ago after initial treatment failure with MTX. Adalimumab failed after 6-months, which was followed by a 6-month course of etanercept along with diet and exercise counseling. At the 6-month etanercept checkup the dermatologist notices in addition to increased BSA involvement, the knuckles of NCD s right-hand middle and ring fingers are showing signs of joint swelling and articular distortion. NCD reports she is sad, unable to concentrate, and no longer enjoys her reading hobby. Her bowel habits are normal and she is adhering to dietary recommendations. Which of the following is the BEST clinical course of action for the dermatologist to take with this patient? A. Keep the patient on etanercept for another 6 weeks to gauge treatment safety and efficacy. 100% 90% 80% 70% 60% 50% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 57% 94% 88% B. Keep the patient on etanercept for another 6 weeks to gauge treatment safety and efficacy, and refer the patient for mental-health evaluation and treatment. C. Refer the patient for evaluation by a rheumatologist, discuss the possibility of switching to secukinumab therapy given the failure of two anti-tnfs; also refer the patient for mental health evaluation and treatment. D. Restart original course of methotrexate therapy and refer the patient to an occupational therapist for treatment of the new hand joint pain and articular distortion symptoms. 40% 30% 20% 10% 0% 23% 13% 8% 7% 1% 3% 0% 2% 4% A B C D Learners showed increased competence in determining the best course of action for treating psoriasis patients who may be showing signs of progression to PsA. While 57% answered correctly at pre-test, an overwhelming majority of learners (94%) responded correctly at post, indicating effective education on the topic of monitoring how/when PSO may progress to PsA.

19 Levels 3-4: Pretest vs. Posttest PSO/PsA Oral Treatment Agents Enduring Pre (n=859) Which of the following therapies is an oral medication with a mechanism(s) of action that targets the phosphodiesterase-4 (PDE-4) pathway? 100% 90% 89% Enduring Post (n=795) Live Post (n=104) A. Apremilast B. Secukinumab C. Ustekinumab D. Methotrexate 80% 70% 60% 50% 40% 36% 73% Enduring participants demonstrated a 103% increase in knowledge on this clinical concept versus pretest, while live participants also demonstrated high clinical competence (89%) on this topic post-activity. 30% 20% 10% 0% 24% 25% 15% 10% 8% 9% 7% 4% 0% A B C D

20 Levels 3-4: Pretest vs. Posttest Management of Cardiovascular Events in PSO Patients Which of the following statements regarding psoriasis and adverse cardiovascular events has been proven true based on clinical evidence? A. Therapeutic intervention in psoriasis directly results in reduced cardiovascular risk of major adverse events. B. Systemic inflammation is a common pathway associated with atherosclerosis, psoriasis, obesity, and insulin resistance/metabolic syndrome. C. Epidemiological studies have determined that psoriasis patients taking a TNF-α inhibitor (TNFi) had lower rates of major CV events compared with the MTX patient cohort at all timepoints. D. Currently available clinical evidence is inadequate to establish a correlation between cardiovascular risk of major adverse events and psoriasis. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Enduring Pre (n=859) Enduring Post (n=795) Live Post (n=104) 75% 69% 37% 30% 25% 22% 15% 11% 11% 5% 0% 0% A B C D Knowledge improvement on this clinical subtopic was dramatic, with a 214% increase in the number of correct responses taking place from pre-test to enduring post-test, indicating increased competence in the ability to manage psoriasis-related cardiovascular events. At the same time, results indicate further education is needed to demonstrate that the systemic inflammation pathway is currently a theory and yet to be proven by clinical evidence. Wide variation in correct post-test responses in live activity versus enduring was likely due in part to variable faculty teaching styles and expertise levels.

21 Levels 3-4: Activity Impact Self-reported activity impact Yes and/or Validated Practice No Increased knowledge 83% 17% Increased competence 81% 19% Improved performance 80% 20% Improved patient outcomes 78% 22% This activity was highly effective. The majority of learners stated their performance (80%) or patient outcomes (78%) will improve as a result, or that the activity validated their current psoriasis/psa treatment practices. N=700; see comments in appendix

22 Level 4: Practice Change Change in diagnostic and assessment protocols for psoriasis, PsA, and co-morbid conditions 33% Change in referral procedures for psoriasis, PsA, and comorbid conditions 38% Other change(s) 3% This activity validated my current practice; no changes will be made 24% 0% 10% 20% 30% 40% 76% of learners will make at least one change to their practice as a result of the activity, or stated the activity validated their current psoriasis/psa treatment practices. N=700; multiple responses allowed; specific changes outlined in appendix

23 Level 5: 45-Day Follow-up Survey Change in Screening Practice Screening and/or treating PsO/PsA patients for renal disease 30% Referring suspect PsA patients to rheumatologists 24% Screening and/or treating PsO/PsA patients for cardiovascular disease 21% The activity validated my screening practice, no changes have been made 7% 0% 5% 10% 15% 20% 25% 30% 35% 45 days post-activity, 93% of learners reported making at least one screening-related change to their practice. N=18; multiple responses allowed

24 Level 5: 45-Day Follow-up Survey Change in Treatment Practice Prescribing or dispensing anti-tnf inhibitors for PsO/PsA 33% Prescribing or dispensing IL-12/IL-23 inhibitors for PsO/PsA 26% Prescribing or dispensing IL-17 inhibitors for PsO/PsA 15% The activity validated my treatment practice, no changes have been made 19% 0% 5% 10% 15% 20% 25% 30% 35% 45 days post-activity, 81% of learners reported making at least one treatment-related change to their practice. N=18; multiple responses allowed

25 Level 5: 45-Day Follow-up Survey Change in Pharmacy Practice Counseled prescribers and/or patients regarding novel PsO/PsA therapies 33% Filled prescriptions for novel PsO/PsA therapies 26% The activity validated my pharmacy practice, no changes have been made 33% 0% 10% 20% 30% 40% Since completing the activity, 33% of pharmacy learners now counsel patients and prescribers on novel psoriasis/psa therapies, while 26% have filled a novel psoriasis/psa therapy prescription. N=18; multiple responses allowed

26 Patient Care Impact Number of patients affected by these changes each month: 3% 1% 9% 0 29% >50 58% Changes in PSO/PsA screening, referrals, and prescribing practice will impact from at least 2,753 to more than 8,652 patients each month. This assumes data in chart above is representative of all healthcare professionals in attendance (1,125), who indicated they would change their practice or that their current practice had been validated as a result of their participation in this activity (76%). N=700

27 Barriers to Planned Change Cost 7% Patient compliance issues 11% Lack of time to assess/counsel patients 7% Lack of opportunity (patients) Lack of experience 14% 14% Reimbursement/insurance issues 9% Lack of administrative support 8% Lack of consensus or professional guidelines 4% Lack of resources (equipment) 6% Other 2% No barriers 18% 0% 5% 10% 15% 20% Participants indicated lack of opportunity (patients) and lack of experience (both 14%) as the most common barriers to implementing changes in their practice. Of those who reported barriers, 75% will attempt to address the perceived barrier(s) in order to affect change. N=700; multiple responses allowed

28 Topics of Interest Psoriasis and depression 41% Cardiovascular issues in psoriasis/psa 29% Therapeutic pipeline in psoriasis/psa 15% Biosimilars in psoriasis/psa 13% Other 2% 0% 10% 20% 30% 40% 50% The link between psoriasis and depression (41%) was the most highly rated educational topic of future interest, followed by cardiovascular issues in psoriasis/psa (29%). N=700; multiple responses allowed

29 Contact Information Brittany Puster Director, Educational Development Academy for Continued Healthcare Learning (ACHL) E: P: ext. 134

30 Appendix

31 Level 4: Activity Impact Self-reported activity impact: Improved understanding of disease management This activity will lead to better patient management and increased confidence for me Better screening techniques/markers to look for Interesting to learn about the connection between psoriasis and CVD More confident in diagnosing, assessing comorbidities, and referring to rheumatologist More likely to treat more aggressively, look for comorbidities Systemic treatment options Improved assessment skills Better able to refer appropriately Better able to diagnose and manage these disease states I work with PsA patients more knowledgeable now on depression and other comorbidities Better understanding of comorbidities and the stepwise approach to treatment Earlier assessment of symptoms Up to date now with new therapies Ability to provide better patient education and counseling Equipped to determine the best course of treatment for psoriasis/psa patients This program expanded my treatment toolbox Better able to educate patients Improved understanding for plan of care

32 Level 4: Practice Change Self-reported practice changes: Use more disease-modifying drugs Will arrange for the proper CVD labs Assessing for comorbidities Will collaborate with dermatologist, rheumatologist, and psychiatrist to fully treat psoriasis, PsA, and related comorbidities Screening PSO pts. with >10% BSA more aggressively Recommending that every member of my medical team becomes educated and up-to-date on this topic Refer to guidelines to assist with diagnosis and management Checking for CVD Better able to recognize signs and symptoms Better communication will relay more information to patients Understanding/implementing CASPAR criteria Incorporating proper patient assessment and evaluation Be more aggressive in prescribing new medications Screening for PsA more often More prompt referrals Increased patient education More knowledgeable of the psoriasis/psa-related effects on depression Screening for depression More available agents better able to choose the best course of treatment for a given patient More likely to treat aggressively and refer out when needed Earlier referrals Taking a more systemic approach to treating the patient Incorporate alternative therapies with evidencebased methods