Nutritional and Metabolic Diseases

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Shilpa Venkatachalam, PhD

Laura Stradford, MPH

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

We have established a governance structure with highly engaged patients and stakeholders who will serve on a Patient Governor Group (PGG) and Research Advisory Board (RAB) to ensure Patient Power participant privacy and transparency about research activities. Online tools and a mobile application at me securely capture patient data. The software tools built include real-time connection to the adaptive version of NIH Patient Reported Outcomes Measurement Information System (PROMIS) instruments capturing patient reported data that minimizes participant burden and allows participants to immediately view their scores if they choose. The Patient Power App runs on both web browsers and smartphones with data stored in the Amazon Web Services (AWS) cloud, not on a participant's smartphone or browser. The App has four key design pillars: (1) Patient engagement, community integration and education by incorporating GHLF bloggers and chronic disease news and social media engagement to the app for education, support and research findings to be shared directly and immediately with those living with registry-eligible chronic conditions; (2) Personal longitudinal health and medication tracking by providing participants' access to their actively contributed patient reported outcome (PRO) and other health-related data (e.g. current and past medications). We will use messaging to encourage participants to regularly update their information, including medication information. For example, we may remind participants to contribute their medication information with the following message: "You don't have any active medications. You can record your medications in Patient Power. By adding your active medications, you will be able to see how your symptoms have changed since starting a new medication. Click here to start entering medications". (3) Health care decision making by allowing App users to share health tracking reports at their discretion with their providers or caregivers; and (4) Research opportunities by providing a platform where an array of new research opportunities can be browsed by participants to combat chronic diseases. The combination of solid governance structure with well-developed policies and procedures, engaged patient community, collaborative relationships with many research partners and our innovatively convenient and mobile approach to data collection make Patient Power a unique and powerful patient-led initiative in chronic disease research.

PatientSpot Formerly Known as ArthritisPower

University of Alabama at Birmingham

Global Healthy Living Foundation

Director, Patient-Centered Research Operations and Ethical Oversight

Necrosis

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Spondylarthropathies

Ankylosis

Spondylarthropathy

Three hundred and fifty consecutive AS patients fulfilling the modified New York criteria for the classification of AS (5), and with a new anti-TNF agent prescription (either for the first time or switched) in the last two weeks period will be included. Treatment with anti-TNF agents will be in accordance with the regulations of Turkish Social Security Agency (SGK) on the initiation and continuation of anti-TNF agents in AS, as well as ASAS/EULAR recommendations for the management of AS (29, 30).

Servet Akar, Prof

The purpose of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents in ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course and to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that predominantly affects sacroiliac joints and spine. It is the prototype of spondyloarthritides (SpA) and one of the most common rheumatic diseases. Sacroiliitis is the earliest manifestation of disease and accompanying with spinal involvement cause inflammatory back pain (IBP). IBP usually starts insidiously in the early adulthood and typically it is felt deep in the buttock and/or lower lumbar regions. It improves with activity and returns with the rest and is usually accompanied by morning stiffness lasting at least 30 minutes. Involvement of the spine in patients with AS is usually not limited to the sacroiliac joints and lumbar region and usually it extends up to the thoracic and cervical segment. Currently the only sign that is diagnostic for AS is radiographic sacroiliitis. However radiography detects structural changes and take up to ten years to appear unequivocally.

In some patients bone tenderness due to enthesitis may be the primary complaint. Arthritis in the hips and shoulders occur in some patients and is associated with worse prognosis. Typical arthritis pattern in AS patients is asymmetric and usually involves the lower extremity joints. There are several extra-articular features of AS and the most common is acute anterior uveitis.

Until recently treatment options for AS were limited and based on non-steroidal anti-inflammatory drugs (NSAIDs), traditional disease modifying anti-rheumatic drugs (DMARDs) for the rheumatoid arthritis and physical therapy. The last decade witnessed a major advance in AS therapy with the use of anti-tumor necrosis factor (anti-TNF) agents. Anti-TNF agents have a substantial effect not only the axial disease but also in peripheral arthritis, enthesitis and extra-articular features (like psoriasis and inflammatory bowel disease). Currently there are four anti-TNF agents approved for AS: (1) infliximab which is a monoclonal chimeric antibody and given at a dose of 5 mg/kg every 6-8 weeks; (2) etanercept which is human TNF receptor fusion protein and administered subcutaneously at a dose of 50 mg/once a week; (3) adalimumab which is a humanized monoclonal antibody and administered as subcutaneous injection at a dose of 40 mg fortnightly; and (4) golimumab which is a fully human monoclonal antibody and administered subcutaneously at a dose of 50 mg once a month.

Since there is no head-to-head studies comparing the anti-TNF agents in the treatment of AS patients there is no ranking for the prescription of anti-TNF agents. Mixed treatment comparisons (that is statistical model allowing the simultaneous multiple meta-analysis of different pair-wise comparisons) between infliximab, adalimumab and etanercept did not show a statistically significant difference. Indeed similar improvements in Bath ankylosing spondylitis activity index (BASDAI 50) scores and ASAS partial remission (between 45.2% to 51.0% BASDAI 50 and 22.1% to 22.4% for partial remission) have been reported in randomized controlled clinical trials.

Although many AS patients respond very well to anti-TNF therapy, a considerable amount of them do not and additionally a significant proportion of patients have to stop their treatment. In clinical practice the reported 1-year and 2-year drug survival rates for anti-TNF agents are 70-85% and 60-75%, respectively.Moreover in a substantial proportion of patients either increase in the administered dosage or dosing frequency have become necessary. Therefore factors, which can predict the response or related with the primary or secondary non-response for anti-TNF treatment have a growing attention among treating specialists. In a study providing an overview of clinical trials and observational studies showed that increased acute phase reactants, higher disease activity, functional status, younger age, and HLA-B27 positivity were independent baseline predictors of response to anti-TNF treatment and increased acute phase reactants, presence of peripheral arthritis, and male sex were the predictors of long-term drug survival.

Immunogenicity refers to development of antibodies by the adaptive immune system in response to foreign substances. The development of anti-drug antibodies were extensively studied in rheumatoid arthritis and it was shown that anti-drug antibodies has a varying impact on the clinical efficacy depending on whether these antibodies are neutralizing or non-neutralizing. Recent review demonstrated that neutralizing antibodies are associated with a reduced chance of achieving a minimal disease activity or clinical remission, decreased drug survival, increased dose escalation and adverse drug reactions in RA patients. However data regarding the immunogenicity in patients treated with AS is scarce and somewhat controversial. In a small study including 38 AS patients treated with infliximab de Vries et al showed that anti-infliximab antibodies was found significantly more often (59% vs 5%) and mean serum through infliximab levels were significantly lower in ASAS20 non-responders. In the above-mentioned study infusion reactions were also seemed to be associated with the development of anti-drug antibodies. In another study de Vries et al (26) were found no antibodies to etanercept and similar serum etanercept levels in responder and non-responder AS patients (n=53). Same group also observed that anti-adalimumab antibodies were become detectable in 31% of AS (n=35) patients in 6 months period and this corresponded with diminished serum drug levels.

Arends et al reported that 0 to 30% of AS patients (n=60) developed anti-drug antibodies during one year of follow-up of anti-TNF treatment and patients with anti-IFN or anti-ADA antibodies had significantly lower drug serum levels.

The objective of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents. The assessment of demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course will be also evaluated. Via this study, it might also be possible to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.

During the serum sample aquisition whole blood samples with EDTA will be collected and stored.

Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study

Does Immunogenicity Have an Influence on the Efficacy of Anti-tumor Necrosis Factor (Anti-TNF) Therapy in Patients With Ankylosing Spondylitis (AS): An Inception Cohort Study

It will be measured in mg/L or other measurement levels by using ELISA

It will be measured in AU/mL or other measurement levels by using ELISA

In order to evaluate function BASDAI will be evaluated in numeric rating scale (0-10)

In order to evaluate function BASFI will be evaluated in numeric rating scale (0-10)

ASDAS-CRP (the preferred version) will be calculated by using the following formula:

0.12 X Back pain + 0.06 X Duration of morning stiffness + 0.11 X Patient global + 0.07 X Peripheral pain / swelling + 0.58 X Ln (CRP + 1)

Izmir Katip Celebi University

Prof

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PatientSpot Formerly Known as ArthritisPower	NCT03840928	Rheumatoid Arth... Ankylosing Spon... Fibromyalgia Gout Crohn Disease Juvenile Idiopa... Lupus Erythemat... Myositis Osteoarthritis Osteoporosis Psoriasis Psoriatic Arthr... Scleroderma Dermatomyositis Inflammatory Bo... Polymyositis Axial Spondyloa... Diffuse Idiopat... Polymyalgia Rhe... Giant Cell Arte... Temporal Arteri... Wegener Relapsing Polyc... Undifferentiate... Spinal Cord Inj... Alzheimer Disea... Amyotrophic Lat... Ataxia Bell Palsy Brain Tumor Cerebral Aneury... Epilepsy Guillain-Barre ... Headache Head Injury Hydrocephalus Lumbar Disc Dis... Meningitis Multiple Sclero... Muscular Dystro... Neurocutaneous ... Parkinson Disea... Stroke Cluster Headach... Tension-Type He... Chronic Obstruc... Asthma Lung Cancer Cystic Fibrosis Sleep Apnea Eczema Alopecia Chronic Inflamm... Unstable Angina Heart Attack Heart Failure Arrythmia Valve Heart Dis... High Blood Pres... Congenital Hear... Peripheral Arte... Diabetes Chronic Liver D... Obesity		19 Years -	Global Healthy Living Foundation
Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study	NCT02687620	Ankylosing Spon... Axial Spondyloa...		18 Years -	Izmir Katip Celebi University

Spots Global Cancer Trial Database for axial spondyloarthritis