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

W Benjamin Nowell1, Elaine Karis2, Kelly Gavigan1

  • 1Patient-Centered Research, Global Healthy Living Foundation, Upper Nyack, NY, USA.

Rheumatology and Therapy
|November 29, 2021
PubMed
Abstract

Insights

Methotrexate (MTX) use in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) causes substantial nausea and fatigue. Digital remote monitoring can detect these medication side effects in real time.

Area of Science:

  • Rheumatology
  • Digital Health
  • Pharmacovigilance

Background:

  • Quantifying methotrexate (MTX)-associated side effects in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) is challenging with traditional methods.
  • Digital data collection and remote patient monitoring offer new approaches to assess medication tolerability.
  • Self-controlled case series methods were employed to analyze MTX-related symptoms.

Purpose of the Study:

  • To implement digital data collection for remote patient monitoring of MTX-associated side effects.
  • To quantify the magnitude and frequency of MTX-related nausea and fatigue in RA and PsA patients.
  • To utilize self-controlled case series analytic methods to understand MTX-related symptoms.

Main Methods:

  • Phase 1: Cross-sectional survey of RA or PsA patients (oral MTX users) from the ArthritisPower® Registry.
  • Phase 2: Longitudinal study of current MTX users assessing nausea and fatigue using PROMIS® 1-day measures.
  • Comparison of within-person PROMIS scores between risk (6-36h post-dose) and control (96-144h post-dose) windows using mixed models.

Main Results:

  • 671 participants completed the baseline survey; 53% were current MTX users.
  • 61% of current MTX users reported MTX-associated side effects, most frequently fatigue (46%).
  • Significant increases in PROMIS nausea (P<0.0001) and fatigue (P=0.0003) were observed in the risk window compared to baseline.

Conclusions:

  • Digital remote patient monitoring enables real-time detection and management of medication tolerability issues.
  • The study demonstrated substantial nausea and fatigue temporally related to weekly MTX use in RA and PsA patients.
  • Novel study designs controlling for between-person confounding are effective in assessing medication side effects.
Keywords:
Adverse eventsFatigueMethotrexateNauseaPatient-reported outcome measures

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