Novel Approach Uses a Smartphone App to Remotely Quantify RA Patients’ Temporally Related Unwanted Symptoms Related to Methotrexate Administration

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Jessica Daitch

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New CreakyJoints ArthritisPower Study Published in Rheumatology and Therapy

UPPER NYACK, NY (December 20, 2021) – Today CreakyJoints®, the digital, international patient community for people with all forms of arthritis and part of the Global Healthy Living Foundation, announced the publication of a new peer-reviewed article describing how their ArthritisPower mobile app may be used to capture patient-reported experiences on a rheumatic disease medication such as methotrexate (MTX), specifically for short-term symptoms that are temporally related to dose administration. Researchers found that nearly two-thirds of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients experience methotrexate side effects (including fatigue and nausea) and that for many, the experience of such symptoms is much more intense in the 1-2 days after each weekly dose is taken. This study’s unique design that compares patients’ symptoms measured in the 1-2 days after taking MTX to their symptoms measured several days later demonstrates the high value of a smartphone-based strategy for remote therapeutic monitoring. It also demonstrates that the use of digital technology to assess medication-related symptoms is both feasible and acceptable to patients. The study, “Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower^® Registry,” was published in Rheumatology and Therapy (28 Nov. 2021).

Previous studies have confirmed that the Patient Reported Outcomes Measurement Information System (PROMIS) developed by the National Institutes of Health reliably captures important patient experiences across physical, mental, and social health domains. Dozens of PROMIS measures are available in the CreakyJoints’ ArthritisPower Research Registry, which researchers in this study used to collect information about patients’ experience with MTX therapy, a commonly prescribed medication for RA, PsA, and other forms of autoimmune arthritis. MTX has a reasonable effectiveness and safety profile that has been well documented in prior studies but is known to induce unwanted symptoms among some patients who take it.

“In this study, we used a self-controlled case series study design using electronic patient-reported outcome measures (e-PROMs) to generate real-world evidence regarding patients’ experiences and treatment side effects. We found that the majority of current MTX users report side effects, such as fatigue and nausea, with mean changes in these symptoms measured shortly after each weekly dose that exceeds a minimally important difference (MID),” said W. Benjamin Nowell, PhD, Director, Patient-Centered Research, CreakyJoints and principal investigator of ArthritisPower. “While these results may not be particularly surprising and serve to reinforce findings from prior research, it’s noteworthy that we were able to measure the change in symptoms that fluctuate appreciably over the week in relation to the timing of MTX use. While patient-provider interactions occurring during traditional office visits can assess a medication’s effectiveness to improve disease activity over weeks and months, they may miss the mark to capture patients’ real-life experience of taking medications that may involve untoward side effects that vary greatly according to when the treatment is taken. If side effects are perceived by the patient as unmanageable, then patients will forego taking the medication, increasing their risk for disease worsening or complications.”

Dr. Nowell is also the coauthor of a newly published article in Musculoskeletal Care (8 Dec. 2021) titled, “The Development and Validation of a Patient-Perceived Methotrexate Intolerance Scale for Use in Adult Rheumatoid Arthritis Patients,” which is the first known scale with favorable measurement properties to evaluate methotrexate intolerance in adults using a patient-centered perspective.

Measurement of Unwanted Symptoms Temporally Related to MTX Dose Administration

In the Rheumatology and Therapy study, 85 current MTX users contributed regular e-PROM data within-week of dose administration related to nausea or fatigue, which allowed for correlation of side effect onset and severity with the timing of weekly administration. Among participants, 39.8 percent were on a biologic DMARD and 59.3 percent were on a non-biologic DMARD only. Of the participants reporting MTX-associated nausea at baseline, 41 percent (16/39) experienced worsened nausea using a MID of 3 units. Of the participants reporting MTX-associated fatigue at baseline, 41 percent (21/51) experienced worsened fatigue using an MID of 3 units. Using an alternative cutoff for MID of 5 units, the corresponding proportions were 31 percent (12/39) for nausea and 39 percent (20/51) for fatigue. Net, about one-third of patients in this sample experienced meaningful worsening of nausea or fatigue in the day following their weekly MTX dose, with a magnitude of change exceeding the MID.

“By stratifying the results according to self-reported symptoms measured before assessment began, we were able to quantify the severity of important symptoms that are bothersome to a large minority of patients. These important observations would have been obscured if only reported at a group level. This study’s findings also offer evidence for the convergent validity of the specific PROMIS instruments used in this study, which have not been previously evaluated in RA patients,” said Dr. Jeff Curtis, MD, MS, MPH, Marguerite Jones Harbert – Gene V. Ball Endowed Professor of Medicine in Rheumatology and Immunology at the University of Alabama at Birmingham and co-principal investigator of the ArthritisPower registry.

Dr. Curtis continued, “The magnitude and frequency of temporally related MTX-associated side effects in rheumatoid arthritis patients has been difficult to quantify in the past because traditional assessments are collected in office. This study demonstrates that patients are open to tracking their treatment experience and associated symptoms, remotely, using a smartphone app, thereby providing researchers with new insights regarding the scope of important side effects that may impact adherence. More patients and providers are becoming comfortable with virtual telehealth appointments and remote patient and remote therapeutic monitoring. It’s increasingly apparent that being able to capture PRO data digitally will be essential to understanding the individual patients’ experience of living with arthritis and its management.”

In this study, participants were recruited from within the ArthritisPower Patient-Powered Research Network Registry. To be eligible for the study, ArthritisPower participants need to be residents of the United States aged 19 and older (or aged 21 if from Puerto Rico), with a self-reported physician diagnosis of RA or PsA. After completing a prescreening questionnaire to determine further eligibility, patients currently taking oral MTX were invited to participate in the longitudinal study, which required at least 1 dose taken in the prior month and use of MTX for less than 10 years. In the absence of data indicating a tolerance threshold for duration of MTX therapy, the 10-year limit was chosen to strike a balance between possible adjustment to MTX tolerance over time and enabling adequate participation in the survey. MTX use was permitted either alone (i.e., monotherapy) or in combination with other DMARDs.

This study was sponsored by Amgen Inc.

About ArthritisPower

Created by CreakyJoints®, ArthritisPower® is the first-ever patient-centered research registry for joint, bone, and inflammatory skin conditions, as well as arthritis and rheumatological manifestations of gastrointestinal-tract (GI) conditions. With tens of thousands of consented arthritis patients, the free ArthritisPower mobile and desktop application allows patients to track their disease and participate in voluntary research studies in a secure and accessible manner. Results from ArthritisPower studies are frequently published in peer-reviewed journals and presented at medical meetings in the United States and around the world. ArthritisPower Patient Governors serve as gatekeepers for researchers who seek to access registry data or solicit the community to participate in unique, voluntary studies. To learn more and join ArthritisPower, visit ArthritisPower.org.

About Creakyjoints

CreakyJoints® is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research. We represent patients in English and Spanish through our popular social media channels, our websites, and the 50-State Network, which includes more than 1,600 trained volunteer patient, caregiver, and health care activists.

Part of the Global Healthy Living Foundation, CreakyJoints also has a patient-reported outcomes registry called ArthritisPower® (ArthritisPower.org), which includes tens of thousands of consented arthritis patients who track their disease while volunteering to participate in longitudinal and observational research. CreakyJoints publishes the popular “Raising the Voice of Patients” series, which offers downloadable patient-centered educational and navigational tools for managing chronic illness. It also hosts PainSpot (PainSpot.org), a digital risk-assessment tool for musculoskeletal conditions and injuries, and eRheum (eRheum.org), for telehealth and virtual-care support. All programming is free, always. For more information and to become a member, visit CreakyJoints.org.

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Global Healthy Living Foundation: ghlf.org

Facebook: facebook.com/CreakyJoints & facebook.com/GlobalHealthyLivingFoundation

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About Global Healthy Living Foundation
The Global Healthy Living Foundation is a 501(c)(3) nonprofit organization whose mission is to improve the quality of life for people with chronic illnesses (such as arthritis, osteoporosis, migraine, psoriasis, inflammatory bowel disease, and cardiovascular disease) by advocating for improved access to health care at the community, state, and federal levels, and amplifying education and awareness e!orts within its social media framework. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the digital community for millions of arthritis patients and caregivers worldwide who seek education, support, activism, and patient-centered research through our ArthritisPower® (ArthritisPower.org) Research Registry. In response to the COVID-19 pandemic, GHLF started a Patient Support Program, informed by a patient council made up of people living with a wide range of chronic illnesses, that now serves more than 30,000 people. Via CreakyJoints, GHLF also hosts PainSpot (PainSpot.org), a digital risk-assessment tool for musculoskeletal conditions and injuries, and eRheum (eRheum.org), for telehealth and virtual-care support. Visit ghlf.org for more information.