Dataset Information

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower^® Registry.

ABSTRACT:

Introduction

The magnitude and frequency of temporally related methotrexate (MTX)-associated side effects in rheumatoid arthritis (RA) or psoriatic arthritis (PsA) patients are difficult to quantify using traditional research methods. As proof of concept designed in part to implement digital data collection for remote patient monitoring, we conducted a study implementing self-controlled case series analytic methods to understand MTX-related symptoms in RA or PsA.

Methods

In study phase 1, adults with RA or PsA from the ArthritisPower^® Registry (past or current oral MTX users) participated in a cross-sectional survey. In phase 2, current MTX users participated in a longitudinal study and completed the Patient-Reported Outcomes Measurement Information System (PROMIS^®) 1-day nausea/vomiting and fatigue measure. Within-person change in PROMIS scores between risk (6-36 h post-dose) and control (96-144 h post-dose) windows were compared using mixed models.

Results

The baseline survey was completed by 671 participants (mean age: 54 years, 88% female, 92% white, 79% with RA). Among current MTX users (353/671 [53%]), most reported MTX-associated side effects (216/353 [61%]), most frequently fatigue (161/353 [46%]). Among phase 2 participants with (n = 39) and without (n = 84) baseline nausea, mean increase in PROMIS nausea was 5.1 units (P < 0.0001) and 0.7 units (P = 0.135), respectively; among those with (n = 51) and without (n = 72) baseline fatigue, mean increase in PROMIS fatigue was 3.9 units (P = 0.0003) and 0.4 units (P = 0.554), respectively.

Conclusions

Digital remote patient monitoring presents an opportunity to detect and address medication tolerability in real time. Using a novel study design to control for between-person confounding, the magnitude of nausea and fatigue experienced by participants with RA and PsA temporally related to weekly MTX use was substantial.

SUBMITTER: Nowell WB

PROVIDER: S-EPMC8628141 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower<sup>®</sup> Registry.

Nowell W Benjamin WB Karis Elaine E Gavigan Kelly K Stradford Laura L Zhao Hong H Chen Lang L Stryker Scott S Yun Huifeng H Venkatachalam Shilpa S Kricorian Gregory G Xie Fenglong F Curtis Jeffrey R JR

Rheumatology and therapy 20211128 1

<h4>Introduction</h4>The magnitude and frequency of temporally related methotrexate (MTX)-associated side effects in rheumatoid arthritis (RA) or psoriatic arthritis (PsA) patients are difficult to quantify using traditional research methods. As proof of concept designed in part to implement digital data collection for remote patient monitoring, we conducted a study implementing self-controlled case series analytic methods to understand MTX-related symptoms in RA or PsA.<h4>Methods</h4>In study ...[more]

PMID: 34843092

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Dataset Information

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower^® Registry.

Introduction

Methods

Results

Conclusions

Publications

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower<sup>®</sup> Registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower® Registry.

Introduction

Methods

Results

Conclusions

Publications

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower<sup>®</sup> Registry.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower^® Registry.