PATIENT-POWERED RESEARCH

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2 PATIENT-POWERED RESEARCH NPF NATIONAL VOLUNTEER CONFERENCE CHICAGO, JULY 28, 2013 Andrew D. Robertson, Ph.D. Chief Scientific and Medical Officer Larry Green, M.D. Chair, Research Committee

3 PATIENT-POWERED RESEARCH OUTLINE Treatment Updates Research Highlights NPF-funded research Other research The gut microbiome Patient-Powered Research

4 TREATMENT UPDATES OUTLINE What is the pipeline? Oral treatments Topical treatments Injectable/systemic treatments

5 TREATMENT UPDATES WHAT IS THE PIPELINE?

6 ORAL TREATMENTS

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8 TOPICAL TREATMENTS

9 INJECTABLE/SYSTEMIC TREATMENTS

10 NPF FUNDED RESEARCH 2013 DISCOVERY GRANTS - $50,000 Onur Boyman, M.D. (U. Zurich) identify the contributions of different molecules and immune cells to psoriasis Cong-Qiu Chu, M.D., Ph.D. (Oregon Health & Science U.) - explore a new class of therapeutic agents known as small interfering RNA (sirna) Dafna Gladman, M.D. (U. Toronto) determine if the DNA in psoriatic disease patients' sperm carries markers that predispose their children to psoriatic diseases Matthew Hayden, M.D., Ph.D. (Columbia U.) - investigate how two pro-inflammatory molecules, tumor necrosis factor-alpha (TNF-alpha) and interleukin 17 (IL 17) work together to promote psoriasis Nicole Ward, Ph.D. (Case Western Reserve U.) - test the hypothesis that an enzyme called Kallikrein 6 is a key player in the development of psoriasis

11 NPF-FUNDED RESEARCH 2013 TRANSLATIONAL GRANT - $200,000 Theoharis Theoharides, M.D., Ph.D. Tufts University School of Medicine Explore how stress contributes to psoriasis and how molecules derived from chamomile might interrupt this psoriasis-stress connection.

12 RESEARCH HIGHLIGHTS RESEARCH FROM OUTSIDE OF THE NPF Causes Treatments & Co-Morbidities The Microbiome

13 SORE THROATS & PSORIASIS TONSIL INFECTIONS MAY EXPLAIN SOME PSORIASIS Tonsils are important for immune defense of the oral cavity

14 SORE THROATS & PSORIASIS BACKGROUND Throat infections by β-haemolytic streptococci associated with initiation and exacerbation of psoriasis Psoriasis patients are more vulnerable to throat infections

15 SORE THROATS & PSORIASIS PRESENT STUDY - (2013) Clin Exp Immunol, June 10, published online Focused on patients with frequent sore throat Found psoriasis tonsils more frequently infected by β- haemolytic Streptococci compared with recurrentlyinfected tonsils from patients without skin disease. Psoriasis patients also had more T cells expressing proinflammatory IL-23 receptor and a skin-homing protein called CLA.

16 SORE THROATS & PSORIASIS SUMMARY & CONCLUSIONS In some people, tonsil infections may stimulate production of pro-inflammatory T cells that migrate to skin Present study - patients had a known association of sore throat and exacerbation of their disease Previous studies - tonsillectomy decreased disease activity for some psoriasis patients Benefits of tonsillectomy may be restricted to people with genetic predisposition & history of psoriasis with sore throat.

17 TREATING PSORIASIS SYSTEMIC TREATMENTS MAY PROTECT HEART Psoriasis associated with increased risk of heart disease Present study* does treating psoriasis reduce risk of heart disease? *J Intern Med Feb;273(2):

18 SYSTEMICS MAY PROTECT HEART DANISH STUDY OF ELECTRONIC HEALTH RECORDS* 2400 patients with severe psoriasis 693 treated with biological agents, 799 with methotrexate Followed frequency of cardiovascular disease events Biologics and methotrexate associated with about half the frequency of cardiovascular disease events seen in patients on other therapies *J Intern Med Feb;273(2):

19 2013 KEYSTONE SYMPOSIA CONFERENCE - THE GUT MICROBIOME

20 THE GUT MICROBIOME A CLEAR ROLE IN HEALTH Genetically Identical Mice, Identical Diet Different Gut Microbiota -

21 THE EFFECTOR/REGULATORY IMMUNE NETWORK Example: T Cells Pro-inflammatory * Anti-inflammatory *Antigen- Presenting Cell Interacts with Microbes

22 THE GUT MICROBIOME The Effector/Regulatory Immune Network Mammalian GI tract microbiome essential for development of immune system. Alterations of microbiome may lead to immune dysregulation in gut (e.g., IBD) and in more distant sites (e.g., RA, MS), leading to autoimmune disease. Meeting focus - role of the microbiota in balancing the effector (e.g., Th cells) and regulatory (e.g., Treg cells) responses in immunity Assemble bacteriologists & immunologists with clinicians; no previous meetings like this.

23 MAKING CONNECTIONS ACROSS DISCIPLINES Examples Christophe Benoist (Harvard U.) Studies on immune system in mice hosting one gut microbe add skin to analysis? Sarah Jackson (J. Clinical Investigation) Review article on under-studied disease? Daniel Beiting (U Penn Veterinary Med.) Psoriasis in veterinary setting? Sarkis Mazmanian (CalTech) Explore possibility of psoriatic disease research? CCFA

24 PATIENT-POWERED RESEARCH THE LITHIUM STORY IN ALS Small study identified lithium as possible treatment for slowing ALS PatientsLikeMe community of patient researchers, decided to test idea themselves Found no effect of lithium Published - Nat Biotechnol May;29(5):411-4

25 PATIENT-POWERED RESEARCH THE CONCEPT Participatory health/medicine, patient-centered Citizen science, crowdsourcing Health social networks Patient advocacy groups, e.g., AIDS

26 STEPS IN RESEARCH Identify Questions Prioritize Questions Choose What To Measure Design Experiment Interpret Data Analyze Data Collect Data Share Results

27 PATIENT-POWERED RESEARCH WHAT HAS THE NPF BEEN DOING? Long history of patient surveys National Volunteer Conference Patient participation in 2012 Research Symposium* Patient access to clinical trials visit

28 PATIENT-POWERED RESEARCH WHAT WILL THE NPF BE DOING? Vision patients as collaborators in research Developing pilot projects Possible big project Patient Powered Research Network Developing proposal for PPRN to submit to Patient-Centered Outcomes Research Institute (PCORI)

29 Planning: PCORI Ideal Patient-Powered Research Network Who - Patients, caregivers or clinicians Participate in patient-centered outcomes research, contribute research ideas, data At least 50,000 patients Strategies to enhance and report the diversity and the representativeness of the patient community as it expands Accumulate relevant outcomes data from at least 80% of the membership Governance - patient control Establish relationships with researchers Generate research questions Dissemination communicate research findings to patients and providers Share Clinical Data - members to contribute electronic clinical data Collect New Data - explore approaches for patients to collect self-reported data Merge into Bigger Network Participate in program-wide steering committee Aim for standards-based, interoperable approach to building PPRN In subsequent funding cycle, merge with clinical research data networks

30 PCORI Patient-Powered Research Network DRAFT VISION Large community of patient researchers led by a small group of patient volunteers High level of support for the patient researcher community e.g., engagement with researchers; clinicians; excellent IT capabilities including top-notch web-based patient-researcher portal; facilitation of discussion; questions answered rapidly and well Informative & compelling continuing education program for patient researchers Lively, energetic and productive discussions among patients and researchers regarding e.g., ideas for research projects; design, implementation, analysis and interpretation of studies; dissemination of results Productive; highest quality research results Rapid and effective communication of results

31 PCORI PATIENT-POWERED RESEARCH (PPRN) NETWORK Pieces of the VISION for the Psoriasis PPRN Patient- Reported Data PatientsLikeMe Patients NPF Individual Researchers - Basic to Clinical Web-Based PPRN Home Venue for Discussion Clinical Data EMA Dermatology Dermatology Comparative Effectiveness Research Network (DCERN)

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